Effect of Oleactiv® on LDL Oxidability

NCT05221346 | Completed

• 1 other identifier: 2021-A00508-33
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypercholesterolemia

Keywords

Polyphenols; LDL oxidability

Outcome Measures

Primary Outcomes (1)

• Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group

  LDL oxidability

  3 months

Secondary Outcomes (11)

• Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group

  3 months

• Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group

  3 months

• Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group

  3 months

• Change from baseline of reverse transport of cholesterol after 3 weeks of food supplement consumption compared to placebo group

  3 months

• Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group

  3 months

Study Arms (2)

Plant food supplement

EXPERIMENTAL

* Dietary supplements in capsule form * 1 capsule per day at breakfast

Dietary Supplement: Plant food supplement

Maltodextrin

PLACEBO COMPARATOR

* Dietary supplements in capsule form * 1 capsule per day at breakfast

Dietary Supplement: Maltodextrin

Interventions

Plant food supplement DIETARY_SUPPLEMENT

Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers

Plant food supplement

Maltodextrin DIETARY_SUPPLEMENT

Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers

Maltodextrin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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,
• 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,

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

NutrINvest

Lille, 59019, France

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jean-Michel Lecerf, MD

  Institut Pasteur de Lille - NutrInvest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 3, 2022
• Study Start: December 13, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)