Status:
COMPLETED
Effect of Oleactiv® on LDL Oxidability
Lead Sponsor:
Institut Pasteur de Lille
Conditions:
Hypercholesterolemia
Eligibility:
MALE
40-70 years
Phase:
NA
Brief Summary
Oleactiv® have previously demonstrated beneficial effects in an animal model of diet-induced atherosclerosis. After a 12-week supplementation, a substantial reduction of aortic fatty streak area has b...
Eligibility Criteria
Inclusion
- Male aged between 40 and 70 years (limits included),
- BMI between 20 and 30 kg / m² (limits included)
- Weight over 65kg (to respect volume blood collection reglementation)
- Fasting plasma LDL cholesterol between 1.16 g / L and 1.9 g / L (limits included) if the cardiovascular risk is low OR Fasting plasma LDL cholesterol between 1.0 g / L and 1.9 g / L (limits included) if the cardiovascular risk is moderate (SCORE calculated according to the European Society of Cardiology 2019)
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme.
Exclusion
- Dyslipidemia or hyperlipidemia:
- Fasting total cholesterol ≥ 3.0 g / L
- Fasting triglycerides\> 2 g / L
- with heterozygous familial hypercholesterolemia
- Hypertensive-treated
- Diabetes treated or not with medication
- Taking drugs known to have an impact on lipid metabolism (statin, ezetimibe, colestyramine, fibrate, etc.) in the month preceding inclusion and / or likely to consume them during the test
- Consuming food supplements or functional foods known to have an influence on cholesterolemia (phytosterol, phytostanol, red rice yeast, policosanols, beta-glucans at a dose greater than 3 g / d) in the month preceding the inclusion and / or likely to take during the test
- Consuming probiotics in the form of a food supplement in the month preceding inclusion and / or likely to take them during the test
- Following or having followed a hypocaloric diet (energy intake \<1,500 kCal / day) in the month preceding inclusion and / or likely to undertake this diet during the test
- Who donated blood in the 3 months preceding inclusion
- Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting)
- High level athlete (physical activity for 1 hour per day)
- Smoking more than 5 cigarettes per day
- Bariatric surgery or who has a gastroplasty ring
- Consuming more than 3 standard drinks of alcoholic beverage daily,
- Consuming drugs,
- Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
- Known allergy to one of the component of the supplement (Grape, olive, artichoke, blackcurrant or pomegranate) or to corn.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05221346
Start Date
December 13 2021
End Date
October 11 2022
Last Update
December 7 2022
Active Locations (1)
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1
NutrINvest
Lille, France, 59019