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OpenTrials
Completed

NCT Number: NCT04482530

Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

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Key information

Conditions

Healthy

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

This is an interventional randomized, single blinded, cross over and controlled study.

The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.

The secondary objective is:

-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)

  • Informed consent form
  • Clinical examination
  • Medical history
  • Anthropometric characteristics
  • Blood biochemical and hematological assessment
  • Compliance test with the original matrix will be carried out

Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods.

Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix.

After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below).

Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method.

Visit 7 will be the last visit of the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subject
  • Subject over 65 years (included)
  • Subject over 61 kg (included)
  • Able to consume the 80g of fruit pastes in 10 minutes
  • Subject with a dentition consistent with the fruit paste consumption in 10 minutes
  • Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2
  • Subject agreeing to provide written consent

Exclusion criteria

  • Subject with acute pathology (unstable or terminal pathology, severe dementia)
  • Subject with renal failure (clearance < 60 ml/min)
  • Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)
  • Person with diabetes
  • Subject on food restriction
  • Subject undergoing chemotherapy
  • Subject with gastrointestinal pathology
  • Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Treatment and study plan

fruit paste matrice

Other

Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Primary outcomes

  1. Area Under the Curve (AUC) of glycemia

    Time frame: Day 0

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  2. Maximum Plasma Concentration (Cmax) of glycemia

    Time frame: Day 0

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  3. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time frame: Day 0

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  4. Area Under the Curve (AUC) of glycemia

    Time frame: Day 7

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  5. Maximum Plasma Concentration (Cmax) of glycemia

    Time frame: Day 7

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  6. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  7. Area Under the Curve (AUC) of glycemia

    Time frame: day 14

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  8. Maximum Plasma Concentration (Cmax) of glycemia

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  9. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  10. Area Under the Curve (AUC) of glycemia

    Time frame: day 21

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  11. Maximum Plasma Concentration (Cmax) of glycemia

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  12. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  13. Area Under the Curve (AUC) of glycemia

    Time frame: day 28

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  14. Maximum Plasma Concentration (Cmax) of glycemia

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  15. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Secondary outcomes

  1. Area Under the Curve (AUC) of fructose

    Time frame: Day 0

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  2. Maximum Plasma Concentration (Cmax) of fructose

    Time frame: Day 0

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  3. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time frame: Day 0

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  4. Area Under the Curve (AUC) of fructose

    Time frame: Day 7

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  5. Maximum Plasma Concentration (Cmax) of fructose

    Time frame: Day 7

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  6. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time frame: Day 7

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  7. Area Under the Curve (AUC) of fructose

    Time frame: Day 14

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  8. Maximum Plasma Concentration (Cmax) of fructose

    Time frame: Day 14

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  9. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time frame: Day 14

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  10. Area Under the Curve (AUC) of fructose

    Time frame: Day 21

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  11. Maximum Plasma Concentration (Cmax) of fructose

    Time frame: Day 21

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  12. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time frame: Day 21

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  13. Area Under the Curve (AUC) of fructose

    Time frame: Day 28

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  14. Maximum Plasma Concentration (Cmax) of fructose

    Time frame: Day 28

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  15. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time frame: Day 28

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  16. Area Under the Curve (AUC) of glucagon

    Time frame: day 0

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  17. Maximum Plasma Concentration (Cmax) of glucagon

    Time frame: day 0

    : Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  18. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  19. Area Under the Curve (AUC) of glucagon

    Time frame: day 7

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  20. Maximum Plasma Concentration (Cmax) of glucagon

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  21. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time frame: Day 7

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  22. Area Under the Curve (AUC) of glucagon

    Time frame: Day 14

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  23. Maximum Plasma Concentration (Cmax) of glucagon

    Time frame: Day 14

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  24. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time frame: Day 14

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  25. Area Under the Curve (AUC) of glucagon

    Time frame: Day 21

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  26. Maximum Plasma Concentration (Cmax) of glucagon

    Time frame: Day 21

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  27. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time frame: Day 21

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  28. Area Under the Curve (AUC) of glucagon

    Time frame: Day 28

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  29. Maximum Plasma Concentration (Cmax) of glucagon

    Time frame: Day 28

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  30. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time frame: Day 28

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  31. Area Under the Curve (AUC) of CCK

    Time frame: Day 0

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  32. Maximum Plasma Concentration (Cmax) of CCK

    Time frame: Day 0

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  33. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time frame: Day 0

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  34. Area Under the Curve (AUC) of CCK

    Time frame: Day 7

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  35. Maximum Plasma Concentration (Cmax) of CCK

    Time frame: Day 7

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  36. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time frame: Day 7

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  37. Area Under the Curve (AUC) of CCK

    Time frame: Day 14

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  38. Maximum Plasma Concentration (Cmax) of CCK

    Time frame: Day 14

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  39. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time frame: Day 14

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  40. Area Under the Curve (AUC) of CCK

    Time frame: Day 21

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  41. Maximum Plasma Concentration (Cmax) of CCK

    Time frame: Day 21

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  42. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time frame: Day 21

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  43. Area Under the Curve (AUC) of CCK

    Time frame: Day 28

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  44. Maximum Plasma Concentration (Cmax) of CCK

    Time frame: Day 28

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  45. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time frame: Day 28

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  46. Area Under the Curve (AUC) of Grehlin

    Time frame: Day 0

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  47. Maximum Plasma Concentration (Cmax) of Grehlin

    Time frame: Day 0

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  48. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  49. Area Under the Curve (AUC) of Grehlin

    Time frame: day 7

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  50. Maximum Plasma Concentration (Cmax) of Grehlin

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  51. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  52. Area Under the Curve (AUC) of Grehlin

    Time frame: day 14

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  53. Maximum Plasma Concentration (Cmax) of Grehlin

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  54. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  55. Area Under the Curve (AUC) of Grehlin

    Time frame: day 21

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  56. Maximum Plasma Concentration (Cmax) of Grehlin

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  57. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  58. Area Under the Curve (AUC) of Grehlin

    Time frame: day 28

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  59. Maximum Plasma Concentration (Cmax) of Grehlin

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  60. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  61. Area Under the Curve (AUC) of leptin

    Time frame: day 0

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  62. Maximum Plasma Concentration (Cmax) of leptin

    Time frame: day 0

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  63. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  64. Area Under the Curve (AUC) of leptin

    Time frame: day 7

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  65. Maximum Plasma Concentration (Cmax) of leptin

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  66. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  67. Area Under the Curve (AUC) of leptin

    Time frame: day 14

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  68. Maximum Plasma Concentration (Cmax) of leptin

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  69. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  70. Area Under the Curve (AUC) of leptin

    Time frame: day 21

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  71. Maximum Plasma Concentration (Cmax) of leptin

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  72. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  73. Area Under the Curve (AUC) of leptin

    Time frame: day 28

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  74. Maximum Plasma Concentration (Cmax) of leptin

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  75. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  76. Area Under the Curve (AUC) of GLP1

    Time frame: day 0

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

  77. Maximum Plasma Concentration (Cmax) of GLP1

    Time frame: day 0

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  78. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  79. Area Under the Curve (AUC) of GLP1

    Time frame: day 7

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  80. Maximum Plasma Concentration (Cmax) of GLP1

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  81. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  82. Area Under the Curve (AUC) of GLP1

    Time frame: day 14

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  83. Maximum Plasma Concentration (Cmax) of GLP1

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  84. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  85. Area Under the Curve (AUC) of GLP1

    Time frame: day 21

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

  86. Maximum Plasma Concentration (Cmax) of GLP1

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  87. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  88. Area Under the Curve (AUC) of GLP1

    Time frame: day 28

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  89. Maximum Plasma Concentration (Cmax) of GLP1

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  90. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  91. Area Under the Curve (AUC) of incretines

    Time frame: day 0

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  92. Maximum Plasma Concentration (Cmax) of incretines

    Time frame: day 0

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  93. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  94. Area Under the Curve (AUC) of incretines

    Time frame: day 7

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  95. Maximum Plasma Concentration (Cmax) of incretines

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  96. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  97. Area Under the Curve (AUC) of incretines

    Time frame: day 14

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  98. Maximum Plasma Concentration (Cmax) of incretines

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  99. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  100. Area Under the Curve (AUC) of incretines

    Time frame: day 21

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  101. Maximum Plasma Concentration (Cmax) of incretines

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  102. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  103. Area Under the Curve (AUC) of incretines

    Time frame: day 28

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  104. Maximum Plasma Concentration (Cmax) of incretines

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  105. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  106. Area Under the Curve (AUC) of insulin

    Time frame: day 0

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  107. Maximum Plasma Concentration (Cmax) of insulin

    Time frame: day 0

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  108. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  109. Area Under the Curve (AUC) of insulin

    Time frame: day 7

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  110. Maximum Plasma Concentration (Cmax) of insulin

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  111. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  112. Area Under the Curve (AUC) of insulin

    Time frame: day 14

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  113. Maximum Plasma Concentration (Cmax) of insulin

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  114. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  115. Area Under the Curve (AUC) of insulin

    Time frame: day 21

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  116. Maximum Plasma Concentration (Cmax) of insulin

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  117. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  118. Area Under the Curve (AUC) of insulin

    Time frame: day 28

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  119. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  120. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  121. Area Under the Curve (AUC) of urea

    Time frame: day 0

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  122. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 0

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  123. Time of Maximum Plasma Concentration (Tmax) of urea

    Time frame: day 0

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  124. Area Under the Curve (AUC) of urea

    Time frame: day 7

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  125. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 7

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  126. Time of Maximum Plasma Concentration (Tmax) of urea

    Time frame: day 7

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  127. Area Under the Curve (AUC) of urea

    Time frame: day 14

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  128. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 14

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  129. Time of Maximum Plasma Concentration (Tmax) of urea

    Time frame: day 14

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  130. Area Under the Curve (AUC) of urea

    Time frame: day 21

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  131. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 21

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  132. Time of Maximum Plasma Concentration (Tmax) of urea

    Time frame: day 21

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  133. Area Under the Curve (AUC) of urea

    Time frame: day 28

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  134. Maximum Plasma Concentration (Cmax) of urea

    Time frame: day 28

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  135. Time of Maximum Plasma Concentration (Tmax) of urea

    Time frame: day 28

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  136. Questionnaire of satiety

    Time frame: at time 0 after ingestion in Day 0

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  137. Questionnaire of satiety

    Time frame: at time 60 after ingestion in Day 0

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  138. Questionnaire of satiety

    Time frame: at time 180 after ingestion in Day 0

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  139. Questionnaire of satiety

    Time frame: at time 0 after ingestion in Day 7

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  140. Questionnaire of satiety

    Time frame: at time 60 after ingestion in Day 7

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  141. Questionnaire of satiety

    Time frame: at time 180 after ingestion in Day 7

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  142. Questionnaire of satiety

    Time frame: at time 0 after ingestion in Day 14

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  143. Questionnaire of satiety

    Time frame: at time 60 after ingestion in Day 14

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  144. Questionnaire of satiety

    Time frame: at time 180 after ingestion in Day 14

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  145. Questionnaire of satiety

    Time frame: at time 0 after ingestion in Day 21

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  146. Questionnaire of satiety

    Time frame: at time 60 after ingestion in Day 21

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  147. Questionnaire of satiety

    Time frame: at time 180 after ingestion in Day 21

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  148. Questionnaire of satiety

    Time frame: at time 0 after ingestion in Day 28

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  149. Questionnaire of satiety

    Time frame: at time 60 after ingestion in Day 28

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  150. Questionnaire of satiety

    Time frame: at time 180 after ingestion in Day 28

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  151. Questionnaire of acceptability

    Time frame: day 0

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  152. Questionnaire of acceptability

    Time frame: day 7

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  153. Questionnaire of acceptability

    Time frame: day 14

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  154. Questionnaire of acceptability

    Time frame: day 21

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  155. Questionnaire of acceptability

    Time frame: day 28

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  156. Facilited individual interview

    Time frame: day 40

    Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort

  157. Focus group

    Time frame: day 40

    Focus group interview to assess organoleptic, satiety and gastrointestinal comfort

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
  • Unité de recherche CSGA, INRAE Dijon

Registry information

Official study title

Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept

Acronym: Fruisenior

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2020
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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