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OpenTrials
Completed

NCT Number: NCT05456815

The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype

Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet and phenotype in postprandial glucose responses is unclear.

The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.

63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years will be included in the study, comprising a characterization period of 3 weeks and a completely controlled dietary intervention of 9 weeks. During these 9 weeks, glucose will be continuously monitored to measure postprandial glucose responses to standard foods/meals.

There are minor risks for the research subjects of this study. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.

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Key information

Conditions

Postprandial Glucose Responses Glucose Metabolism

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6700 EV, Netherlands

About this study

Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet, i.e. the other consumed food products and meals, and phenotype in postprandial glucose responses is unclear. A repetitive design and a standardized diet are necessary to determine the variation in postprandial glucose responses to a meal or food product irrespective of the diet.

The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within and between individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.

The study population consists of 63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years, and who are weight stable (± <3 kg) for at least three months prior to inclusion.

The study comprises a characterization period of three weeks, followed by a fully controlled dietary intervention trial of nine weeks. In the characterization period, the phenotype of participants will be determined by measures on anthropometrics, immune function, oxidative stress, advanced glycation end-products, cognitive performance, microbiota and gut health, amylase, genetics, and circulating metabolites. The dietary intervention consists of three repetitive rounds of three weeks, in which we test food products in a cross-over setting. Participants will consume test products that fall in the same food category, but differ in glycaemic index/carbohydrate content. Part of these products is provided by industrial partners, of which the original products are reformulated to be reduced in glycaemic index/carbohydrate content. During the 9-week dietary intervention all foods are provided, giving us a complete and detailed picture of food and nutrient intake during this period. The standardized diet follows the average consumption pattern of the study population. Throughout the intervention, interstitial glucose concentrations will be measured using continuous glucose monitoring (CGM) and physical activity will be monitored with an accelerometer.

This study is related to a broad general population. There are minor risks for the research subjects of this study. Placing a continuous glucose sensor generally does not cause pain, but could result in the loss of a drop of blood, or slight skin irritation after wearing. Blood sampling will be performed via a cannula or venapunction and the insertion can be a bit painful and may cause a bruise. During the characterization period, in total 215 mL of blood will be collected in a 3-week timespan. In the following 9 weeks 108 mL, and at the end of the intervention 34 mL blood will be collected. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Apparently healthy men and women
  • BMI of 25 - 40 kg/m2
  • Age 45-75 years
  • Weight stable (± <3 kg) for at least two months prior to inclusion

Exclusion criteria

  • Diagnosed with type 1 or type 2 diabetes
  • Diseases or prior surgeries affecting the stomach, liver, or intestines
  • Food allergies/intolerances for products used in the study design
  • Receiving medication or supplements interfering with glucose metabolism (as judged by our research physician)
  • Regular use of medication interfering with immune function (e.g. corticosteroids, immune blockers, as judged by our research physician)
  • Donated blood within 2 months prior to the screening
  • Anaemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for women
  • Veins not suitable for venflon needle
  • Allergy/intolerance to medical skin adhesives
  • Dietary habits interfering with the study design (e.g. vegetarian, vegan, ketogenic diet)
  • Intention to change the intensity of exercise during the study period
  • Current smokers
  • Alcohol intake ≥14 alcoholic beverages per week (women) or ≥21 alcoholic beverages per week (men)
  • Being pregnant or lactating
  • Use of soft and/or hard drugs
  • Unable/unwilling to download a research application on the mobile phone
  • Participation in another study that involves an intervention within two months prior to the intervention
  • Working at the division of Human Nutrition and Health of Wageningen University and Research or the Food, Health and Consumer research group of Wageningen University and Biobased Research

Treatment and study plan

Standardized diet

Other

During 9 weeks all food products will be standardized and provided by the Research Unit. The standardized diet is based on the average food composition in the Netherlands.

Other names: 9-week fully controlled dietary intervention

Primary outcomes

  1. Blood glucose profile

    Time frame: Continuous for 9 weeks

    Interstitial glucose concentrations, as measured by continuous glucose monitoring

Secondary outcomes

  1. Short-term well-being

    Time frame: Baseline

    Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

  2. Short-term well-being

    Time frame: 1 hour post-ingestion

    Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

  3. Short-term well-being

    Time frame: 2 hours post-ingestion

    Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

  4. Short-term well-being

    Time frame: 4 hours post-ingestion

    Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

  5. Postprandial glucose blood levels

    Time frame: Baseline

    Postprandial glucose responses in blood upon a mixed meal challenge

  6. Postprandial glucose blood levels

    Time frame: 30 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  7. Postprandial glucose blood levels

    Time frame: 60 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  8. Postprandial glucose blood levels

    Time frame: 90 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  9. Postprandial glucose blood levels

    Time frame: 120 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  10. Postprandial glucose blood levels

    Time frame: 180 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  11. Postprandial glucose blood levels

    Time frame: 240 minutes post-ingestion

    Postprandial glucose responses in blood upon a mixed meal challenge

  12. Postprandial insulin blood levels

    Time frame: Baseline

    Postprandial insulin responses in blood upon a mixed meal challenge

  13. Postprandial insulin blood levels

    Time frame: 30 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  14. Postprandial insulin blood levels

    Time frame: 60 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  15. Postprandial insulin blood levels

    Time frame: 90 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  16. Postprandial insulin blood levels

    Time frame: 120 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  17. Postprandial insulin blood levels

    Time frame: 180 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  18. Postprandial insulin blood levels

    Time frame: 240 minutes post-ingestion

    Postprandial insulin responses in blood upon a mixed meal challenge

  19. Postprandial metabolite blood levels

    Time frame: Baseline

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  20. Postprandial metabolite blood levels

    Time frame: 30 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  21. Postprandial metabolite blood levels

    Time frame: 60 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  22. Postprandial metabolite blood levels

    Time frame: 90 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  23. Postprandial metabolite blood levels

    Time frame: 120 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  24. Postprandial metabolite blood levels

    Time frame: 180 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  25. Postprandial metabolite blood levels

    Time frame: 240 minutes post-ingestion

    Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

  26. Postprandial lipid profiling

    Time frame: Baseline

    Postprandial lipid profiling in blood upon a mixed meal challenge

  27. Postprandial lipid profiling

    Time frame: 30 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  28. Postprandial lipid profiling

    Time frame: 60 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  29. Postprandial lipid profiling

    Time frame: 90 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  30. Postprandial lipid profiling

    Time frame: 120 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  31. Postprandial lipid profiling

    Time frame: 180 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  32. Postprandial lipid profiling

    Time frame: 240 minutes post-ingestion

    Postprandial lipid profiling in blood upon a mixed meal challenge

  33. Postprandial fatty acid blood levels

    Time frame: Baseline

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  34. Postprandial fatty acid blood levels

    Time frame: 30 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  35. Postprandial fatty acid blood levels

    Time frame: 60 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  36. Postprandial fatty acid blood levels

    Time frame: 90 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  37. Postprandial fatty acid blood levels

    Time frame: 120 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  38. Postprandial fatty acid blood levels

    Time frame: 180 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  39. Postprandial fatty acid blood levels

    Time frame: 240 minutes post-ingestion

    Postprandial fatty acid concentrations in blood upon a mixed meal challenge

  40. Postprandial gut hormone blood levels

    Time frame: Baseline

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  41. Postprandial gut hormone blood levels

    Time frame: 30 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  42. Postprandial gut hormone blood levels

    Time frame: 60 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  43. Postprandial gut hormone blood levels

    Time frame: 90 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  44. Postprandial gut hormone blood levels

    Time frame: 120 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  45. Postprandial gut hormone blood levels

    Time frame: 180 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  46. Postprandial gut hormone blood levels

    Time frame: 240 minutes post-ingestion

    Postprandial gut hormone concentrations in blood upon a mixed meal challenge

  47. Cholesterol concentration

    Time frame: Baseline

    Fasting plasma cholesterol concentration

  48. Postprandial blood glucose levels

    Time frame: Baseline

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  49. Postprandial blood glucose levels

    Time frame: 15 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  50. Postprandial blood glucose levels

    Time frame: 30 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  51. Postprandial blood glucose levels

    Time frame: 45 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  52. Postprandial blood glucose levels

    Time frame: 60 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  53. Postprandial blood glucose levels

    Time frame: 90 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  54. Postprandial blood glucose levels

    Time frame: 120 minutes post-ingestion

    Postprandial glucose responses in blood upon an oral glucose tolerance test

  55. Postprandial blood insulin levels

    Time frame: Baseline

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  56. Postprandial blood insulin levels

    Time frame: 15 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  57. Postprandial blood insulin levels

    Time frame: 30 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  58. Postprandial blood insulin levels

    Time frame: 45 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  59. Postprandial blood insulin levels

    Time frame: 60 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  60. Postprandial blood insulin levels

    Time frame: 90 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  61. Postprandial blood insulin levels

    Time frame: 120 minutes post-ingestion

    Postprandial insulin responses in blood upon an oral glucose tolerance test

  62. Physical activity

    Time frame: Continuous for 9 weeks

    Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)

  63. Physical activity

    Time frame: Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention

    Continuous physical activity levels, measured by ActivPAL3 micro (PAL Technologies, Glasgow, Scotland) during 3 non-consecutive weeks

  64. Body fat distribution

    Time frame: Baseline

    Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI)

  65. Liver fat content

    Time frame: Baseline

    Liver fat content as measured by MRS

  66. HbA1c

    Time frame: Baseline

    HbA1c

  67. Fasting glucose concentration

    Time frame: Baseline

    Fasting glucose concentration

  68. Fasting insulin concentration

    Time frame: Baseline

    Fasting insulin concentration

  69. Circulating cytokines

    Time frame: Baseline

    Circulating plasma cytokines

  70. PBMC composition

    Time frame: Baseline

    Immune function as measured by PBMC composition

  71. PBMC composition

    Time frame: End of intervention (week 12)

    Immune function as measured by PBMC composition

  72. Metabolism immune cell populations

    Time frame: Baseline

    Metabolism of immune cell populations as measured by SCENITH

  73. Immune function

    Time frame: End of intervention (week 12)

    Metabolism of immune cell populations as measured by SCENITH

  74. Immune response

    Time frame: Baseline

    Immune response upon TLR stimulation

  75. Immune response

    Time frame: End of intervention (week 12)

    Immune response upon TLR stimulation

  76. PBMC cytokine production

    Time frame: Baseline

    PBMC cytokine production as measured by intracellular staining

  77. PBMC cytokine production

    Time frame: End of intervention (week 12)

    PBMC cytokine production as measured by intracellular staining

  78. Oxidative stress marker urine

    Time frame: Baseline

    Oxidative stress as measured by free 8-iso PGF2a in urine

  79. Oxidative stress marker urine

    Time frame: End of intervention (week 12)

    Oxidative stress as measured by free 8-iso PGF2a in urine

  80. Oxidative stress in plasma

    Time frame: Baseline

    Oxidative stress as measured by MDA levels in plasma

  81. Oxidative stress in plasma

    Time frame: End of intervention (week 12)

    Oxidative stress as measured by MDA levels in plasma

  82. Oxidative stress in plasma

    Time frame: Baseline

    Oxidative stress as measured by nitrotyrosine in plasma

  83. Oxidative stress in plasma

    Time frame: End of intervention (week 12)

    Oxidative stress as measured by nitrotyrosine in plasma

  84. Advanced glycation end-products (AGEs) blood

    Time frame: Baseline

    AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

  85. Advanced glycation end-products (AGEs) blood

    Time frame: End of intervention (week 12)

    AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

  86. Alpha-dicarbonyl concentrations blood

    Time frame: Baseline

    alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

  87. Alpha-dicarbonyl concentrations blood

    Time frame: End of intervention (week 12)

    alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

  88. AGE accumulation

    Time frame: Baseline

    Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)

  89. AGE accumulation

    Time frame: End of intervention (week 12)

    Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)

  90. Cognitive performance

    Time frame: Baseline

    Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery

  91. Oral microbiota composition

    Time frame: Baseline

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  92. Oral microbiota composition

    Time frame: Week 1 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  93. Oral microbiota composition

    Time frame: Week 2 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  94. Oral microbiota composition

    Time frame: Week 3 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  95. Oral microbiota composition

    Time frame: Week 4 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  96. Oral microbiota composition

    Time frame: Week 5 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  97. Oral microbiota composition

    Time frame: Week 6 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  98. Oral microbiota composition

    Time frame: Week 7 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  99. Oral microbiota composition

    Time frame: Week 8 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  100. Oral microbiota composition

    Time frame: Week 9 dietary intervention

    Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

  101. Fecal microbiota composition

    Time frame: Baseline

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  102. Fecal microbiota composition

    Time frame: Week 1 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  103. Fecal microbiota composition

    Time frame: Week 2 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  104. Fecal microbiota composition

    Time frame: Week 3 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  105. Fecal microbiota composition

    Time frame: Week 4 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  106. Fecal microbiota composition

    Time frame: Week 5 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  107. Fecal microbiota composition

    Time frame: Week 6 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  108. Fecal microbiota composition

    Time frame: Week 7 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  109. Fecal microbiota composition

    Time frame: Week 8 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  110. Fecal microbiota composition

    Time frame: Week 9 dietary intervention

    Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

  111. Self-reported stool consistency

    Time frame: Baseline

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  112. Self-reported stool consistency

    Time frame: Week 1 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  113. Self-reported stool consistency

    Time frame: Week 2 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  114. Self-reported stool consistency

    Time frame: Week 3 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  115. Self-reported stool consistency

    Time frame: Week 4 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  116. Self-reported stool consistency

    Time frame: Week 5 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  117. Self-reported stool consistency

    Time frame: Week 6 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  118. Self-reported stool consistency

    Time frame: Week 7 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  119. Self-reported stool consistency

    Time frame: Week 8 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  120. Self-reported stool consistency

    Time frame: Week 9 dietary intervention

    Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

  121. Transit time

    Time frame: Baseline

    Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces

  122. Transit time

    Time frame: End of intervention (week 12)

    Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces

  123. Salivary amylase concentration

    Time frame: Baseline

    Concentration of salivary amylase

  124. Salivary amylase concentration

    Time frame: End of intervention (week 12)

    Concentration of salivary amylase

  125. Salivary amylase activity

    Time frame: Baseline

    Activity of salivary amylase

  126. Salivary amylase activity

    Time frame: End of intervention (week 12)

    Activity of salivary amylase

  127. Genetic variation amylase genes

    Time frame: Baseline

    SNPs in genes coding for amylase, collected using a mouth swab

  128. Genetic variation metabolism and responses to food

    Time frame: Baseline

    SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab

  129. Habitual dietary intake

    Time frame: Baseline

    Habitual dietary intake assessment with a food frequency questionnaire (FFQ)

  130. Plasma glucose response fries A

    Time frame: Baseline

    Plasma glucose response to fries type A

  131. Plasma glucose response fries A

    Time frame: 2 hours post-ingestion

    Plasma glucose response to fries type A

  132. Plasma glucose response fries B

    Time frame: Baseline

    Plasma glucose response to fries type B

  133. Plasma glucose response fries B

    Time frame: 2 hours post-ingestion

    Plasma glucose response to fries type B

  134. Plasma glucose response fries C

    Time frame: Baseline

    Plasma glucose response to fries type C

  135. Plasma glucose response fries C

    Time frame: 2 hours post-ingestion

    Plasma glucose response to fries type C

  136. Plasma glucose response yoghurt A

    Time frame: Baseline

    Plasma glucose response to yoghurt type A

  137. Plasma glucose response yoghurt A

    Time frame: 2 hours post-ingestion

    Plasma glucose response to yoghurt type A

  138. Plasma glucose response yoghurt B

    Time frame: Baseline

    Plasma glucose response to yoghurt type B

  139. Plasma glucose response yoghurt B

    Time frame: 2 hours post-ingestion

    Plasma glucose response to yoghurt type B

  140. Plasma glucose response yoghurt C

    Time frame: Baseline

    Plasma glucose response to yoghurt type C

  141. Plasma glucose response yoghurt C

    Time frame: 2 hours post-ingestion

    Plasma glucose response to yoghurt type C

  142. Plasma glucose response cake A

    Time frame: Baseline

    Plasma glucose response to cake type A

  143. Plasma glucose response cake A

    Time frame: 2 hours post-ingestion

    Plasma glucose response to cake type A

  144. Plasma glucose response cake B

    Time frame: Baseline

    Plasma glucose response to cake type B

  145. Plasma glucose response cake B

    Time frame: 2 hours post-ingestion

    Plasma glucose response to cake type B

  146. Plasma glucose response cake C

    Time frame: Baseline

    Plasma glucose response to cake type C

  147. Plasma glucose response cake C

    Time frame: 2 hours post-ingestion

    Plasma glucose response to cake type C

  148. Plasma insulin response fries A

    Time frame: Baseline

    Plasma insulin response to fries type A

  149. Plasma insulin response fries A

    Time frame: 2 hours post-ingestion

    Plasma insulin response to fries type A

  150. Plasma insulin response fries B

    Time frame: Baseline

    Plasma insulin response to fries type B

  151. Plasma insulin response fries B

    Time frame: 2 hours post-ingestion

    Plasma insulin response to fries type B

  152. Plasma insulin response fries C

    Time frame: Baseline

    Plasma insulin response to fries type C

  153. Plasma insulin response fries C

    Time frame: 2 hours post-ingestion

    Plasma insulin response to fries type C

  154. Plasma insulin response yoghurt A

    Time frame: Baseline

    Plasma insulin response to yoghurt type A

  155. Plasma insulin response yoghurt A

    Time frame: 2 hours post-ingestion

    Plasma insulin response to yoghurt type A

  156. Plasma insulin response yoghurt B

    Time frame: Baseline

    Plasma insulin response to yoghurt type B

  157. Plasma insulin response yoghurt B

    Time frame: 2 hours post-ingestion

    Plasma insulin response to yoghurt type B

  158. Plasma insulin response yoghurt C

    Time frame: Baseline

    Plasma insulin response to yoghurt type C

  159. Plasma insulin response yoghurt C

    Time frame: 2 hours post-ingestion

    Plasma insulin response to yoghurt type C

  160. Plasma insulin response cake A

    Time frame: Baseline

    Plasma insulin response to cake type A

  161. Plasma insulin response cake A

    Time frame: 2 hours post-ingestion

    Plasma insulin response to cake type A

  162. Plasma insulin response cake B

    Time frame: Baseline

    Plasma insulin response to cake type B

  163. Plasma insulin response cake B

    Time frame: 2 hours post-ingestion

    Plasma insulin response to cake type B

  164. Plasma insulin response cake C

    Time frame: Baseline

    Plasma insulin response to cake type C

  165. Plasma insulin response cake C

    Time frame: 2 hours post-ingestion

    Plasma insulin response to cake type C

Other outcomes

  1. Waist-to-hip ratio

    Time frame: Baseline

    Waist-to-hip ratio

  2. Body mass index

    Time frame: Baseline

    Body mass index

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Acronym: RepEAT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Jul 10, 2023

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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