Effect of Oleactiv® on LDL Oxidability (e-POL)

Pasteur Institute of Lille (IPL)

Status

Completed

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Maltodextrin

Dietary Supplement: Plant food supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05221346

2021-A00508-33

Details and patient eligibility

About

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 been observed. Also, Oleactiv®-supplemented hamsters displayed significant decrease of both non-HDL-cholesterol and triglycerides levels. Also, phenolic compounds from Oleactiv® demonstrated that increase of cholesterol efflux capacity (CEC) is one of the mechanisms that may explain preventive effect on atheroma development.

These effects observed in animals will thus be investigated in human. The main hypothesis of the present study is that phenolic compounds from Oleactiv® may improve LDL oxidability in volunteers with moderate hypercholesterolemia after 3 weeks of consumption.

Enrollment

26 patients

Sex

Male

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.