Skip to main content
OpenTrials
Completed

NCT Number: NCT04731987

Orange Juice, Hesperidin and Their Role in Vascular Health Benefit

Although epidemiological studies have associated the consumption of sugary beverages with adverse health effects, experimental studies have demonstrated that the metabolic response of the human body to fruit juice as compared to artificial beverages is substantially different. Fruit juices do not just provide sugars and related calories, but they are rich sources of bioactive compounds especially of flavonoids. Flavanones constitute a class of flavonoids that are specifically and abundantly found in citrus fruits, with hesperidin being the major compound in orange. From prospective cohort studies, higher intakes of flavanones are associated with a lower incidence of mortality by cardiovascular disease (CVD). This relation is supported by results from a number of animal studies demonstrating a slowdown in atherosclerosis development and vascular protective effects in dietary interventions with flavanones. Randomized, controlled clinical trials to corroborate the suggested vasculo-protective effects of orange juice presumably mediated by the flavanones are scarce and available data do not allow to draw firm conclusions about their efficacy. To fill this gap, the "HESPER-HEALTH study" conducted in humans will assess the vascular protective effects of 100% orange juice consumption and evaluate the contribution of hesperidin in these effects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Predisposition to Cardiovascular Disease Vascular Compliance

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Clermont Ferrand

Clermont-Ferrand, AURA, 63000, France

About this study

This human dietary intervention study is a double blind, randomized, placebo controlled, cross over trial with 3 arms, carried out on subjects with predisposition to cardiovascular diseases (CVD) based on age and overweight. This study aims to demonstrate the vascular protective effects (with Flow Mediated Dilatation (FMD) as main criteria) of the consumption of a flavanone rich orange juice or of orange flavanones by comparison with a control sugary drink alone.

The 42 recruited participants will receive the 3 drinks in a random order. For each subject, the study is divided into 3 identical experimental periods of 45 days (period 1,2,3): including 3 days prior to the beginning of the product intake, during which specific dietary guidelines, samplings and measures will be asked to be performed at home followed by a 6 weeks period of consumption of each of the 3 beverages). A period of 4 to 6 weeks of wash-out is planned between each experimental period.

To summarize: Visit 1 (D-14) = inclusion, Visit 2 (D1: baseline) to 3 (D42) = period 1, Visit 3 (D42) to 4 (D70) = wash out 1, Visit 4 (D70) to 5 (D111) = period 2, Visit 5 (D111) to 6 (D139) = wash out 2, Visit 6 (D139) to 7 (D180) = period 3. The wash-out periods (minimum duration: 4 weeks) may be extended until 6 weeks for the convenience of participants.

The protocol includes a total of 7 visits to PIC/CIC Inserm 1405 of the Clermont-Fd University Hospital.

The total duration of the study will be between 28 and 34 weeks

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Man or post-menopausal woman ;
  • 40-65 years old (inclusive) ;
  • Body Mass Index (BMI)≤ 30 ;
  • Waist circumference ≥80 cm for women, and ≥94 cm for men ;
  • Weight > 46 kg
  • Normal biological balance sheet or considered normal by the investigator
  • No aversion or intolerance to citrus foods ;
  • Accept to limit their total intake of flavonoid rich beverages (tea, coffee, cocoa, wine, fruit juice) to 250 mL/day ;
  • Ability to give informed consent to participate in research ;
  • Willingness to accept randomization and undergo the testing and intervention procedures and deliver stool, blood and urine samples for testing ;
  • Affiliation to Social Security.

Exclusion criteria

  • Treated pre-diabetic or diabetic ;
  • Treated for hypertension ;
  • Use of statins or other medications for lowering cholesterol ;
  • Treated with antibiotics, antifungals, probiotics or prebiotics in the 3 months before the enrolment ;
  • Menopausal hormone replacement therapy ;
  • Diagnosed gastrointestinal illness in the judgement of the investigator ;
  • Any serious medical condition that precludes safe participation in the study, such as coronary artery disease, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer and anemia ;
  • History of eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder in the last 5 years ;
  • Digestive disorders with diarrhea during the 3 months preceding the beginning of the study ;
  • Self-declared vegetarian, vegetalian, vegan ;
  • History of substance abuse or alcohol abuse ;
  • Involvement in a weight loss intervention program (including anti-obesity medication) within the past 3 months or who have had bariatric surgery ;
  • Current smokers (within the last 30 days) ;
  • Use of dietary supplements (vitamins, antioxidants) currently or in the past one month ;
  • Strenuous exercise greater than 6 hours per week ;
  • Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol ;
  • Subjects involved in another clinical trial or being in the exclusion period of another study or having received a total compensation greater than 4,500 euros over the 12 months preceding the start of the trial ;
  • Subject benefiting from a legal protection measure (curatorship, guardianship, safeguard of justice) ;
  • Refusal to participate.

Treatment and study plan

Beverage consumption

Behavioral

Volunteers will consume, in random order, daily 330 ml of 1 experimental beverage per period (Orange Juice, Control Beverage, Control Beverage supplemented with hesperidin) for 6 weeks in each period.

At the beginning and the end of each period, exploration will be conducted at fasted state and at post-prandial state after the administration of a high-fat high-sugar meal.

Primary outcomes

  1. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 1

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

  2. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 42

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

  3. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 70

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

  4. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 111

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

  5. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 139

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

  6. Brachial artery Flow Mediated Dilation (FMD)

    Time frame: Day 180

    The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery in fasted state

Secondary outcomes

  1. Sex

    Time frame: Day -14

    Participant sex (man/women) will be requested.

  2. Age

    Time frame: Day 34

    Participant age (years) will be requested.

  3. Basal Systolic Blood Pressure

    Time frame: Day -14

    Blood pressure measure (mm Hg) with monitor.

  4. Basal Heart Rate

    Time frame: Day -14

    Heart rate measure (beat/min) with monitor.

  5. D-3 visit systolic Blood Pressure (BP)

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Self-monitored blood pressure (mmHg) at home with tensiometer, at home the morning, 3 days before the visit, in fasted state.

  6. D-3 visit diastolic BP

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Self-monitored blood pressure (mmHg) at home with tensiometer, at home the morning, 3 days before the visit, in fasted state.

  7. D-3 visit Heart Rate

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Self-monitored heart rate (beat/min) at home with tensiometer,at home the morning, 3 days before the visit, in fasted state.

  8. FMD post prandial endothelial response 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Assessment of the postprandial endothelial response to a challenge meal (900kcal, fresh cream, sucrose and milk proteins) by measuring FMD (percent) using ultrasound technique, 3h after intake of the full daily dose of study products concomitantly with challenge meal.

  9. FMD post prandial endothelial response 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Assessment of the postprandial endothelial response to a challenge meal by measuring FMD (percent) using ultrasound technique, 6h after intake of the full daily dose of study products concomitantly with challenge meal.

  10. Arterial compliance assessment

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Noninvasive measure with Sphygmocor (AtCor Medical Pty. Ltd) of pulse transit time between carotid artery and femoral artery. The carotid-femoral Pulse Wave Velocity (PWV) (m/sec) is an established index of arterial stiffness,in fasted state.

  11. Rest flow by Flowmetry Laser Doppler (FLD) in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the rest flow using laser-Doppler system at the level of the skin of the hand, in fasted state

  12. Occlusion area by FLD in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the occlusion area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) in fasted state

  13. Hyperaemia area by FLD in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) in fasted state

  14. Hyperaemia area / occlusion area ratio by FLD in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the ratio hyperaemia area / occlusion area determined by FLD.

  15. Maximal flow by FLD in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the maximal flow using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), in fasted state

  16. Hyperaemia half time by FLD in fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia half time using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), in fasted state

  17. Rest flow by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the rest flow using laser-Doppler system at the level of the skin of the hand,3h after intake of the full daily dose of study products concomitantly with challenge meal

  18. Occlusion area by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the occlusion area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 3h after intake of the full daily dose of study products concomitantly with challenge meal

  19. Hyperaemia area by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 3h after intake of the full daily dose of study products concomitantly with challenge meal

  20. Hyperaemia area / occlusion area ratio by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the ratio hyperaemia area/ occlusion area determined by FLD, 3h after intake of the full daily dose of study products concomitantly with challenge meal

  21. Maximal flow by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the maximal flow using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 3h after intake of the full daily dose of study products concomitantly with challenge meal

  22. Hyperaemia half time by FLD 3h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia half time using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 3h after intake of the full daily dose of study products concomitantly with challenge meal

  23. Rest flow by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the rest flow using laser-Doppler system at the level of the skin of the hand, 6h after intake of the full daily dose of study products concomitantly with challenge meal

  24. Occlusion area by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the occlusion area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 6h after intake of the full daily dose of study products concomitantly with challenge meal

  25. Hyperaemia area by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 6h after intake of the full daily dose of study products concomitantly with challenge meal

  26. Hyperaemia area / occlusion area ratio by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the ratio hyperaemia area / occlusion area ratio determined by FLD, 6h after intake of the full daily dose of study products concomitantly with challenge meal

  27. Maximal flow by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the maximal flow using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 6h after intake of the full daily dose of study products concomitantly with challenge meal

  28. Hyperaemia half time by FLD 6h after a challenge meal

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia half time using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement), 6h after intake of the full daily dose of study products concomitantly with challenge meal

  29. Hesperetin concentration in 24h urine

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin in urine (nM) will be measured.

  30. Hesperetin concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin in plasma (nM) will be measured.

  31. Hesperetin catabolites concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin microbial catabolites in plasma (nM) will be measured, on fasted state

  32. Hesperetin concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin in plasma (mM) will be measured, in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  33. Hesperetin catabolites concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin microbial catabolites in plasma (mM) will be measured, in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  34. Hesperetin concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin in plasma (mM) will be measured, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  35. Hesperetin catabolites concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of hesperetin microbial catabolites in plasma (mM) will be measured, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  36. Naringenin concentration in 24h urine

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin in urine (nM) will be measured.

  37. Naringenin catabolites concentration in 24h urine

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin microbial catabolites in urine (nM) will be measured.

  38. Naringenin concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin in plasma (nM) will be measured, on fasted state

  39. Naringenin catabolites concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin microbial catabolites in plasma (nM) will be measured, on fasted state

  40. Naringenin concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin in plasma (mM) will be measured, in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  41. Naringenin catabolites concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin microbial catabolites in plasma (mM) will be measured, in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  42. Naringenin concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin in plasma (mM) will be measure, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  43. Naringenin catabolites concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of naringenin microbial catabolites in plasma (mM) will be measured, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  44. Flavanone concentration in 24h urine

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone in urine (nM) will be measured.

  45. Flavanone catabolites concentration in 24h urine

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone microbial catabolites in urine (nM) will be measured.

  46. Flavanone concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone in plasma (nM) will be measured, on fasted state.

  47. Flavanone catabolites concentration in plasma on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone microbial catabolites in plasma (nM) will be measured, on fasted state

  48. Flavanone concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone in plasma (mM) will be measured, in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  49. Flavanone catabolites concentration in plasma on 3h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone microbial catabolites in plasma (mM) will be measured,in post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  50. Flavanone concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone in urine (nM) will be measured, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  51. Flavanone catabolites concentration in plasma on 6h post prandial test

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Concentration of flavanone microbial catabolites in plasma (mM) will be measured, in post prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  52. Plasma nitrites dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of nitrite plasma concentration (nM) (a biomarker of endothelial activation), on fasted state

  53. Plasma nitroso-thiols dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of nitroso-thiols plasma concentration (nM) (a biomarker of endothelial activation), on fasted state

  54. Plasma Inter-Cellular Adhesion Molecules (ICAM) dosage on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of ICAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state

  55. Plasma ICAM dosage on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of ICAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state

  56. Plasma Vascular-CAM (VCAM) dosage on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of VCAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state

  57. Plasma VCAM dosage on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of VCAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state

  58. Plasma e-selectin dosage on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of e-selectin plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state

  59. Plasma e-selectin dosage on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of e-selectin plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state

  60. Plasma Extracellular Vesicles analyses (EVs) on fasted state

    Time frame: Day 42, Day 111, Day 180

    EVs (a biomarker of endothelial activation) will be isolated from platelet-poor plasma samples and analyzed, on fasted state

  61. EVs analyses on 3h post prandial state

    Time frame: Day 42, Day 111, Day 180

    EVs (a biomarker of endothelial activation) will be isolated from platelet-poor plasma samples and analyzed, on post prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  62. Plasma oxylipins identification on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of oxylipins present in plasma (a biomarker of inflammation and oxidative stress) using a method of profiling, on fasted state

  63. Plasma oxylipin concentration on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of oxylipin plasma concentration (a biomarker of inflammation and oxidative stress), on fasted state

  64. Plasma oxylipins identification on 6h post prandial state

    Time frame: Day 42, Day 111, Day 180

    Determination of oxylipins present in plasma (a biomarker of inflammation and oxidative stress) using a method of profiling, on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  65. Plasma oxylipin concentration on 6h post prandial state

    Time frame: Day 42, Day 111, Day 180

    Determination of oxylipin plasma concentration (a biomarker of inflammation and oxidative stress), on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  66. Plasma Interleukin 6 (IL-6) dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress), on fasted state

  67. Plasma Tumor Necrosis Factor α (TNFα) dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress), on fasted state

  68. Plasma high-sensitivity C-reactive protein (hs-CRP) dosage

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of hs-CRP plasma concentration (mg/L) (a biomarker of inflammation and oxidative stress), on fasted state

  69. Plasma glucose dosage on fasted state

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of glucose plasma concentration (mM) (a metabolic parameter), on fasted state

  70. Plasma glucose dosage on 3h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of glucose plasma concentration (mM) (a metabolic parameter), on post-prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  71. Plasma glucose dosage on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of glucose plasma concentration (mM) (a metabolic parameter), on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  72. -Plasma Triacylglycerol (TAG) dosage on fasted state

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of TAG plasma concentration (g/L) (a metabolic parameter), on fasted state

  73. Plasma TAG dosage on 3h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of TAG plasma concentration (g/L) (a metabolic parameter), on post-prandial state 3h after the concomitant consumption of the study drink and challenge meal, on post-prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  74. Plasma TAG dosage on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of TAG plasma concentration (g/L) (a metabolic parameter), on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  75. Plasma uric acid dosage on fasted state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of uric acid plasma concentration (mM) (a metabolic parameter) method, on fasted state

  76. Plasma uric acid on 3h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of uric acid plasma concentration (mM) (metabolic parameter), on post-prandial state 3h after the concomitant consumption of the study drink and challenge meal.

  77. Plasma uric acid on 6h post prandial state

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of uric acid plasma concentration (mM) (metabolic parameter) will be determined, on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  78. Plasma total cholesterol dosage

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of total cholesterol plasma concentration (mM) (a metabolic parameter), on fasted state

  79. Plasma High Density Lipoprotein cholesterol (HDL-chol) dosage

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of HDL-chol plasma concentration (mM) (a metabolic parameter), on fasted state

  80. Plasma High Density Lipoprotein cholesterol (LDL-chol) calculation

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of LDL-chol plasma concentration (mM) (metabolic parameter), on fasted state

  81. Plasma Total Fatty Acids (FA) dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of total FA plasma concentration (mM) (a metabolic parameter), on fasted state

  82. Serum Insulin dosage

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Determination of insulin serum concentration (mU/L or pM) (a metabolic parameter), on fasted state

  83. Weight measure

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    the body weight (kg) will be recorded with a bathroom scale, on fasted state

  84. Height measure

    Time frame: Day -14

    the body height (cm) will be measured with a stadiometer.

  85. Body Mass Index (BMI) calculation

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    the BMI (kg/m²) will be calculated, on fasted state

  86. Waist circumference measure

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    the waist circumference (cm) will be recorded with a measuring tape, on fasted state

  87. Fat mass ratio determination

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    The percentage of fat mass (percent) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer, on fasted state

  88. Lean mass ratio determination

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    The percentage of lean mass (percent) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer, on fasted state

  89. Water mass ratio determination

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    The percentage of water (percent) (body composition) will be determined using a multi-frequency bioelectrical Impedance Analyzer, on fasted state

  90. RNA profiling on fasted state

    Time frame: Day 42, Day 111, Day 180

    Nutrigenomic analysis will be performed from total Ribo Nucleic Acid (RNA) isolated blood collected in PAXgene Blood RNA Tube. The isolated RNA will be used to perform microarray analyses that allow identification of expression of all genes of the genome, on fasted state

  91. RNA profiling on 6h post prandial state

    Time frame: Day 42, Day 111, Day 180

    Analysis will be performed from total RNA isolated blood collected in PAXgene Blood RNA Tube. The isolated RNA will be used to perform microarray analyses that allow identification of expression of all genes of the genome, on post-prandial state 6h after the concomitant consumption of the study drink and challenge meal.

  92. Gut microbiota profiling

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Identification of the microbiota composition of feces samples (collected by subjects) by performing a genetic sequencing analysis of bacterial DNA.

  93. Plasma carotenoids dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Carotenoids will be quantitated from plasma (nM), on fasted state

  94. Plasma vitamine C dosage

    Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Vitamin C status will be quantified in deproteinized plasma (mg/L), on fasted state

  95. Treatment compliance

    Time frame: Day 42, Day 111, Day 180

    Treatment compliance (percent) will be determined using counting of empty orange drinks brought back by volunteers after the consumption periods

  96. Polyphenol intake

    Time frame: Day 1, Day 42, Day 111, Day 180

    Polyphenol intake (ml/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.

  97. Low-polyphenol diet compliance

    Time frame: Day 1, Day 42, Day 111, Day 180

    Respect (y/n) of a low-polyphenol diet in basal (between Visit 1 - Visit 2) and during treatment consumption periods (between Visit 2 - Visit 3, Visit 4 - Visit 5, Visit 6 - Visit 7) will be determined by a dietician using 3 days food reports completed by volunteers.

  98. Calorie intake

    Time frame: Day 1, Day 42, Day 111, Day 180

    Calorie (kcal/day) intake in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.

  99. Protein intake

    Time frame: Day 1, Day 42, Day 111, Day 180

    Protein (g/day) intake in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.

  100. Lipid intake

    Time frame: Day 1, Day 42, Day 111, Day 180

    Lipid intake (g/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.

  101. Carbohydrate intake

    Time frame: Day 1, Day 42, Day 111, Day 180

    Carbohydrate intake (g/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.

  102. Diet division of protein/lipid/carbohydrate intakes

    Time frame: Day 1, Day 42, Day 111, Day 180

    The overall distribution of the protein/lipid/carbohydrate food intakes (%) will be determined by a dietician using food report completed by volunteers.

  103. Diet stability

    Time frame: Day 180

    Diet stability (y/n) in terms of polyphenols, calories, proteins, carbohydrates and lipids intakes during the whole study will be determined by a dietician using the 4 food reports completed by volunteers.

  104. Biobank for food metabolome

    Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180

    Urine samples will be stored for further assessment of food metabolome to potentially identify new bioactive compounds present in the juice that could contribute to the biological response after orange juice/HESP intake.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Department of Beverage Research, Chair of analysis and technology of plant-based foods, Geisenheim University
  • European Fruit Juice Association (AIJN)
  • UMR 1019, Unité de Nutrition Humaine, INRAE, Auvergne-Rhône Alpes Center

Registry information

Official study title

Orange Juice, Hesperidin and Their Role in Vascular Health Benefit: a Human Double Blind, Randomized, Controlled, Cross Over Study

Acronym: HESPER-HEALTH

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2021
Registry last updated
Jul 19, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.