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

Effect of Oleactiv® on LDL Oxidability in Volunteers With Moderate Hypercholesterolemia - a Controlled, Randomized, Double-blind Study

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Plant food supplement; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59019
    • NutrINvest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plant food supplement; Dietary supplements in capsule form; 1 capsule per day at breakfast	Dietary supplement: Plant food supplement; Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
Placebo Comparator: Maltodextrin; Dietary supplements in capsule form; 1 capsule per day at breakfast	Dietary supplement: Maltodextrin; Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group	LDL oxidability	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group	Total cholesterol, HDL, LDL, Triglycerides,	3 months
Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group	Lipoprotein size	3 months
Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group	Paraoxonase activity	3 months
Change from baseline of reverse transport of cholesterol after 3 weeks of food supplement consumption compared to placebo group	Reverse transport of cholesterol	3 months
Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group	Cholesterol load capacity	3 months
Maximum plasma concentration of phenolic compounds in a 24h-blood collection	Phenolic compounds were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).	3 months
Time of complete elimination of phenolic compounds in a 24h-blood collection	Phenolic compounds were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).	3 months
Maximum plasma concentration of oxidized LDL in a 24h-blood collection	Oxidized LDL were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).	3 months
Maximum concentration of urinary isoprostanes in a 48h-urine collection	Urinary isoprostanes were measured after food supplement consumption at 7 points (from 22h the day before to 8h (T0), T0-6h, T6-10h, T10-14h, T14-24h, T24-32h, T32-48h).	3 months
Change from baseline of carbohydrate metabolism after 3 weeks of food supplement consumption compared to placebo group	glycemia, insulin	3 months
Change from baseline of arterial stiffness after 3 weeks of food supplement consumption compared to placebo group	Arterial stiffness via the Sphygmocor® measuring device	3 months

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Polyphenols; LDL oxidability
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 2021-A00508-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will available only for sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No