Effect of Oleactiv® on LDL Oxidability (e-POL)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plant food supplement
Maltodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesterolemia focused on measuring Polyphenols, LDL oxidability
Eligibility Criteria
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.
Sites / Locations
- NutrINvest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Plant food supplement
Maltodextrin
Arm Description
Dietary supplements in capsule form 1 capsule per day at breakfast
Dietary supplements in capsule form 1 capsule per day at breakfast
Outcomes
Primary Outcome Measures
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group
LDL oxidability
Secondary Outcome Measures
Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group
Total cholesterol, HDL, LDL, Triglycerides,
Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group
Lipoprotein size
Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group
Paraoxonase activity
Change from baseline of reverse transport of cholesterol after 3 weeks of food supplement consumption compared to placebo group
Reverse transport of cholesterol
Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group
Cholesterol load capacity
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).
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).
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).
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).
Change from baseline of carbohydrate metabolism after 3 weeks of food supplement consumption compared to placebo group
glycemia, insulin
Change from baseline of arterial stiffness after 3 weeks of food supplement consumption compared to placebo group
Arterial stiffness via the Sphygmocor® measuring device
Full Information
NCT ID
NCT05221346
First Posted
January 7, 2022
Last Updated
December 6, 2022
Sponsor
Institut Pasteur de Lille
1. Study Identification
Unique Protocol Identification Number
NCT05221346
Brief Title
Effect of Oleactiv® on LDL Oxidability
Acronym
e-POL
Official Title
Effect of Oleactiv® on LDL Oxidability in Volunteers With Moderate Hypercholesterolemia - a Controlled, Randomized, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Pasteur de Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Polyphenols, LDL oxidability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant food supplement
Arm Type
Experimental
Arm Description
Dietary supplements in capsule form
1 capsule per day at breakfast
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Dietary supplements in capsule form
1 capsule per day at breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant food supplement
Intervention Description
Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
Primary Outcome Measure Information:
Title
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group
Description
LDL oxidability
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group
Description
Total cholesterol, HDL, LDL, Triglycerides,
Time Frame
3 months
Title
Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group
Description
Lipoprotein size
Time Frame
3 months
Title
Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group
Description
Paraoxonase activity
Time Frame
3 months
Title
Change from baseline of reverse transport of cholesterol after 3 weeks of food supplement consumption compared to placebo group
Description
Reverse transport of cholesterol
Time Frame
3 months
Title
Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group
Description
Cholesterol load capacity
Time Frame
3 months
Title
Maximum plasma concentration of phenolic compounds in a 24h-blood collection
Description
Phenolic compounds were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).
Time Frame
3 months
Title
Time of complete elimination of phenolic compounds in a 24h-blood collection
Description
Phenolic compounds were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).
Time Frame
3 months
Title
Maximum plasma concentration of oxidized LDL in a 24h-blood collection
Description
Oxidized LDL were measured after food supplement consumption at 7 points (T0, T1h, T2h, T4h, T6h, T10h, T24h).
Time Frame
3 months
Title
Maximum concentration of urinary isoprostanes in a 48h-urine collection
Description
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).
Time Frame
3 months
Title
Change from baseline of carbohydrate metabolism after 3 weeks of food supplement consumption compared to placebo group
Description
glycemia, insulin
Time Frame
3 months
Title
Change from baseline of arterial stiffness after 3 weeks of food supplement consumption compared to placebo group
Description
Arterial stiffness via the Sphygmocor® measuring device
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Lecerf, MD
Organizational Affiliation
Institut Pasteur de Lille - NutrInvest
Official's Role
Principal Investigator
Facility Information:
Facility Name
NutrINvest
City
Lille
ZIP/Postal Code
59019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will available only for sponsor
Learn more about this trial
Effect of Oleactiv® on LDL Oxidability
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