Status:
COMPLETED
Orange Juice, Hesperidin and Their Role in Vascular Health Benefit
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
UMR 1019, Unité de Nutrition Humaine, INRAE, Auvergne-Rhône Alpes Center
Department of Beverage Research, Chair of analysis and technology of plant-based foods, Geisenheim University
Conditions:
Metabolic Syndrome
Vascular Compliance
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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) base...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04731987
Start Date
February 24 2021
End Date
June 20 2023
Last Update
July 19 2024
Active Locations (1)
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1
University Hospital, Clermont Ferrand
Clermont-Ferrand, AURA, France, 63000