Orange Juice, Hesperidin and Their Role in Vascular Health Benefit
HESPER-HEALTH
HESPER-HEALTH
Sponsor study identifier
interventional
50
1 country
1
Study Start
February 24, 2021
Actual (reported)Primary Completion
June 20, 2023
Actual (reported)Study Completion
June 20, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2021
Actual (reported)February 1, 2021
Actual (reported)February 24, 2021
Actual (reported)June 20, 2023
Actual (reported)June 20, 2023
Actual (reported)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
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
Day 42
Brachial artery Flow Mediated Dilation (FMD)
42 subjects between 40 and 65 years old with predisposition to cardiovascular disease will consume daily 330 ml of orange juice naturally rich in hesperidin (drink A) during 6 weeks
42 subjects between 40 and 65 years old with predisposition to cardiovascular disease will consume daily 330 ml of control beverage (drink B)- a soft drink with sugar concentration identical to drink A - during 6 weeks
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital, Clermont Ferrand
Clermont-Ferrand, AURA, 63000, France
Verny MA, Milenkovic D, Macian N, Pereira B, Evrard R, Gilcher C, Steingass CB, Mosoni P, Gladine C, Monfoulet LE, Schweiggert R, Pickering G, Morand C. Evaluating the role of orange juice, HESPERidin in vascular HEALTH benefits (HESPER-HEALTH study): protocol for a randomised controlled trial. BMJ Open. 2021 Nov 30;11(11):e053321. doi: 10.1136/bmjopen-2021-053321.
50 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2021
First Posted
February 1, 2021
Study Start
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
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
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
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
Day 180
Sex
Day -14
Age
Day 34
Basal Systolic Blood Pressure
Day -14
Basal Heart Rate
Day -14
D-3 visit systolic Blood Pressure (BP)
Day 1, Day 42, Day 70, Day 111, Day 139, Day 180
42 subjects between 40 and 65 years old with predisposition to cardiovascular disease will consume daily 330 ml of control beverage (identical to drink B but supplemented with hesperidin to reach level of drink A) during 6 weeks
Contact the study team to confirm eligibility.
February 24, 2021
Actual (reported)Primary Completion
June 20, 2023
Actual (reported)Study Completion
June 20, 2023
Actual (reported)Last Updated
July 19, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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