Hypercholesterolemiae-POLNCT05221346
Effect of Oleactiv® on LDL Oxidability
A study testing Plant food supplement and Maltodextrin in people with Hypercholesterolemia, run by Institut Pasteur de Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Plant food supplement and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 11 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypercholesterolemia
- Being tested
- Plant food supplement, Maltodextrin
- Keywords
- Polyphenols, LDL oxidability
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant food supplementDietary supplement
Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
MaltodextrinDietary supplement
Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
| Study group | Role | What they receive |
|---|---|---|
| Plant food supplement | Experimental | * Dietary supplements in capsule form
* 1 capsule per day at breakfast Receives: Dietary Supplement: Plant food supplement |
| Maltodextrin | Placebo comparator | * Dietary supplements in capsule form
* 1 capsule per day at breakfast Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group
LDL oxidability
Measured: 3 months
Secondary outcomes (11)
Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group
Total cholesterol, HDL, LDL, Triglycerides,
Measured: 3 months
Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group
Lipoprotein size
Measured: 3 months
Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group
Paraoxonase activity
Measured: 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
Measured: 3 months
Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group
Cholesterol load capacity
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months
Change from baseline of carbohydrate metabolism after 3 weeks of food supplement consumption compared to placebo group
glycemia, insulin
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start13 Dec 2021
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221346
- Sponsor's protocol ID
- 2021-A00508-33
- Acronym
- e-POL
- Status last verified
- Dec 2022
- First submitted
- 7 Jan 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will available only for sponsor
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oleactiv® on LDL Oxidability in Volunteers With Moderate Hypercholesterolemia - a Controlled, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT05221346
- Acronym / sponsor ID
- e-POL / 2021-A00508-33
- Conditions
- Hypercholesterolemia
- Keywords
- Polyphenols, LDL oxidability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant food supplement | Experimental | Dietary Supplement: Plant food supplement* Dietary supplements in capsule form * 1 capsule per day at breakfast |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin* Dietary supplements in capsule form * 1 capsule per day at breakfast |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (23 listed)
- Dyslipidemia or hyperlipidemia:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant food supplementFood supplements are consumed during 3 weeks by hypercholesterolemic volunteers | Dietary supplement | Plant food supplement |
| MaltodextrinFood supplements are consumed during 3 weeks by hypercholesterolemic volunteers | Dietary supplement | Maltodextrin |
Primary outcome
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
LDL oxidability
11 secondary outcomes
Change from baseline of lipid metabolism after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Change from baseline of lipoproteins size distribution after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Change from baseline of plasma paraoxonase activity after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Change from baseline of reverse transport of cholesterol after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Change from baseline of cholesterol load capacity after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Maximum plasma concentration of phenolic compounds in a 24h-blood collection
Time frame: 3 months
Time of complete elimination of phenolic compounds in a 24h-blood collection
Time frame: 3 months
Maximum plasma concentration of oxidized LDL in a 24h-blood collection
Time frame: 3 months
Maximum concentration of urinary isoprostanes in a 48h-urine collection
Time frame: 3 months
Change from baseline of carbohydrate metabolism after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Change from baseline of arterial stiffness after 3 weeks of food supplement consumption compared to placebo group
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No. IPD will available only for sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant food supplement and Maltodextrin in people with Hypercholesterolemia, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of LDL oxidability after 3 weeks of food supplement consumption compared to placebo group (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.