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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
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.
University Hospital, Clermont Ferrand
Clermont-Ferrand, AURA, France
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 1
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 42
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 70
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 111
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 139
Brachial artery Flow Mediated Dilation (FMD)
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
Time frame: Day 180
Sex
Participant sex (man/women) will be requested.
Time frame: Day -14
Age
Participant age (years) will be requested.
Time frame: Day 34
Basal Systolic Blood Pressure
Blood pressure measure (mm Hg) with monitor.
Time frame: Day -14
Basal Heart Rate
Heart rate measure (beat/min) with monitor.
Time frame: Day -14
D-3 visit systolic Blood Pressure (BP)
Self-monitored blood pressure (mmHg) at home with tensiometer, at home the morning, 3 days before the visit, in fasted state.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
D-3 visit diastolic BP
Self-monitored blood pressure (mmHg) at home with tensiometer, at home the morning, 3 days before the visit, in fasted state.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
D-3 visit Heart Rate
Self-monitored heart rate (beat/min) at home with tensiometer,at home the morning, 3 days before the visit, in fasted state.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
FMD post prandial endothelial response 3h after a challenge meal
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
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FMD post prandial endothelial response 6h after a challenge meal
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Arterial compliance assessment
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Rest flow by Flowmetry Laser Doppler (FLD) in fasted state
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Occlusion area by FLD in fasted state
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area by FLD in fasted state
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area / occlusion area ratio by FLD in fasted state
Vascular endothelial function in the micro-vascular compartment will be assessed using the ratio hyperaemia area / occlusion area determined by FLD.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Maximal flow by FLD in fasted state
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia half time by FLD in fasted state
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Rest flow by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Occlusion area by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area / occlusion area ratio by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Maximal flow by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia half time by FLD 3h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Rest flow by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Occlusion area by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia area / occlusion area ratio by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Maximal flow by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hyperaemia half time by FLD 6h after a challenge meal
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
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin concentration in 24h urine
Concentration of hesperetin in urine (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin concentration in plasma on fasted state
Concentration of hesperetin in plasma (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin catabolites concentration in plasma on fasted state
Concentration of hesperetin microbial catabolites in plasma (nM) will be measured, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin catabolites concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Hesperetin catabolites concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin concentration in 24h urine
Concentration of naringenin in urine (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin catabolites concentration in 24h urine
Concentration of naringenin microbial catabolites in urine (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin concentration in plasma on fasted state
Concentration of naringenin in plasma (nM) will be measured, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin catabolites concentration in plasma on fasted state
Concentration of naringenin microbial catabolites in plasma (nM) will be measured, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin catabolites concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Naringenin catabolites concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone concentration in 24h urine
Concentration of flavanone in urine (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone catabolites concentration in 24h urine
Concentration of flavanone microbial catabolites in urine (nM) will be measured.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone concentration in plasma on fasted state
Concentration of flavanone in plasma (nM) will be measured, on fasted state.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone catabolites concentration in plasma on fasted state
Concentration of flavanone microbial catabolites in plasma (nM) will be measured, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone catabolites concentration in plasma on 3h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Flavanone catabolites concentration in plasma on 6h post prandial test
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma nitrites dosage
Determination of nitrite plasma concentration (nM) (a biomarker of endothelial activation), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma nitroso-thiols dosage
Determination of nitroso-thiols plasma concentration (nM) (a biomarker of endothelial activation), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma Inter-Cellular Adhesion Molecules (ICAM) dosage on fasted state
Determination of ICAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma ICAM dosage on 6h post prandial state
Determination of ICAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma Vascular-CAM (VCAM) dosage on fasted state
Determination of VCAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma VCAM dosage on 6h post prandial state
Determination of VCAM plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma e-selectin dosage on fasted state
Determination of e-selectin plasma concentration (ng/ml) (a biomarker of endothelial activation), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma e-selectin dosage on 6h post prandial state
Determination of e-selectin plasma concentration (ng/ml) (a biomarker of endothelial activation), on 6h post prandial state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma Extracellular Vesicles analyses (EVs) on fasted state
EVs (a biomarker of endothelial activation) will be isolated from platelet-poor plasma samples and analyzed, on fasted state
Time frame: Day 42, Day 111, Day 180
EVs analyses on 3h post prandial state
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.
Time frame: Day 42, Day 111, Day 180
Plasma oxylipins identification on fasted state
Determination of oxylipins present in plasma (a biomarker of inflammation and oxidative stress) using a method of profiling, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma oxylipin concentration on fasted state
Determination of oxylipin plasma concentration (a biomarker of inflammation and oxidative stress), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma oxylipins identification on 6h post prandial state
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.
Time frame: Day 42, Day 111, Day 180
Plasma oxylipin concentration on 6h post prandial state
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.
Time frame: Day 42, Day 111, Day 180
Plasma Interleukin 6 (IL-6) dosage
Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma Tumor Necrosis Factor α (TNFα) dosage
Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma high-sensitivity C-reactive protein (hs-CRP) dosage
Determination of hs-CRP plasma concentration (mg/L) (a biomarker of inflammation and oxidative stress), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma glucose dosage on fasted state
Determination of glucose plasma concentration (mM) (a metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma glucose dosage on 3h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma glucose dosage on 6h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
-Plasma Triacylglycerol (TAG) dosage on fasted state
Determination of TAG plasma concentration (g/L) (a metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma TAG dosage on 3h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma TAG dosage on 6h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma uric acid dosage on fasted state
Determination of uric acid plasma concentration (mM) (a metabolic parameter) method, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma uric acid on 3h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma uric acid on 6h post prandial state
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.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma total cholesterol dosage
Determination of total cholesterol plasma concentration (mM) (a metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma High Density Lipoprotein cholesterol (HDL-chol) dosage
Determination of HDL-chol plasma concentration (mM) (a metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma High Density Lipoprotein cholesterol (LDL-chol) calculation
Determination of LDL-chol plasma concentration (mM) (metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma Total Fatty Acids (FA) dosage
Determination of total FA plasma concentration (mM) (a metabolic parameter), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Serum Insulin dosage
Determination of insulin serum concentration (mU/L or pM) (a metabolic parameter), on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Weight measure
the body weight (kg) will be recorded with a bathroom scale, on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Height measure
the body height (cm) will be measured with a stadiometer.
Time frame: Day -14
Body Mass Index (BMI) calculation
the BMI (kg/m²) will be calculated, on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Waist circumference measure
the waist circumference (cm) will be recorded with a measuring tape, on fasted state
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Fat mass ratio determination
The percentage of fat mass (percent) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Lean mass ratio determination
The percentage of lean mass (percent) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Water mass ratio determination
The percentage of water (percent) (body composition) will be determined using a multi-frequency bioelectrical Impedance Analyzer, on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
RNA profiling on fasted state
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
Time frame: Day 42, Day 111, Day 180
RNA profiling on 6h post prandial state
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.
Time frame: Day 42, Day 111, Day 180
Gut microbiota profiling
Identification of the microbiota composition of feces samples (collected by subjects) by performing a genetic sequencing analysis of bacterial DNA.
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma carotenoids dosage
Carotenoids will be quantitated from plasma (nM), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Plasma vitamine C dosage
Vitamin C status will be quantified in deproteinized plasma (mg/L), on fasted state
Time frame: Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
Treatment compliance
Treatment compliance (percent) will be determined using counting of empty orange drinks brought back by volunteers after the consumption periods
Time frame: Day 42, Day 111, Day 180
Polyphenol intake
Polyphenol intake (ml/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Low-polyphenol diet compliance
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.
Time frame: Day 1, Day 42, Day 111, Day 180
Calorie intake
Calorie (kcal/day) intake in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Protein intake
Protein (g/day) intake in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Lipid intake
Lipid intake (g/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Carbohydrate intake
Carbohydrate intake (g/day) in basal and during treatment consumption periods will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Diet division of protein/lipid/carbohydrate intakes
The overall distribution of the protein/lipid/carbohydrate food intakes (%) will be determined by a dietician using food report completed by volunteers.
Time frame: Day 1, Day 42, Day 111, Day 180
Diet stability
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.
Time frame: Day 180
Biobank for food metabolome
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.
Time frame: Day -14, Day 1, Day 42, Day 70, Day 111, Day 139, Day 180