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HypercholesterolemiaHEARTNCT04760951

Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects

A study testing TOTUM-070 in people with Hypercholesterolemia and Cardiovascular Risk Factor, run by Valbiotis at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
TOTUM-070
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
4 sitesin 2 countries
Study dates
17 Feb 2021to 17 Feb 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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • I1. From 18 to 70 years (including ranges);
  • I2. Body mass index (BMI) between 18.5 and 35 kg/m² (including ranges);
  • I3. Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (ESC/EAS, 2019);
  • I4. For women: Non-menopausal with the same reliable contraception since at least three months before the beginning of the study and agreeing to keep it during the entire duration of the study (hormonal contraception, intra uterine device or surgical intervention) or menopausal with or without hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded);
  • I5. Weight stable within ± 5% in the last three months;
  • I6. No significant change in food habits or in physical activity in the 3 months before the randomization and agreeing to follow hygiene and dietary (HD) recommendations given during the study;
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  • I7. Good general and mental health according to the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
  • I8. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
  • I9. Affiliated with a social security scheme;
  • I10. Agreeing to be registered on the volunteers in biomedical research.
  • At V0 biological analysis, the subjects will be eligible to the study on the following criteria:
  • I11. Fasting blood LDL cholesterol concentration (using Friedewald estimation method) between 1.3 and 1.9 g/L (included ranges with ± 2% tolerated around);
  • I12. Fasting blood triglycerides concentration ≤ 2.2 g/L;
  • I13. SCORE Cardiovascular Risk Chart < 5% (Low-risk regions of Europe).

Who cannot join

  • E1. Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
  • E2. Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • E3. With a history of ischemic cardiovascular event;
  • E4. Having undergone recent surgical procedure in the past 6 months or in the 6 months to come;
  • E5. With a history of bariatric surgery;
  • E6. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease);
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  • E7. For women: ongoing pregnancy (as evidenced by a positive test for β-HCG (Human Chorionic Gonadotropin), i.e. > 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months or intending to become pregnant within 7 months ahead;
  • E8. Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the inclusion visit V0;
  • E9. Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgen or enzyme inducer, etc) or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
  • E10. Regular intake of dietary supplements or "health foods", or products rich in plant stanol or sterol (like Pro-Activ® or Danacol® products), rich in long chain omega-3 fatty acids (especially soft gels containing fish oils), or in other substances intended to reduce cholesterol or glycemia or stopped less than 3 months before the inclusion visit V0;
  • E11. Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the randomization (for example consumed in the month before the randomization);
  • E12. With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient;
  • E13. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study;
  • E14. With extreme eating habits (e.g. skipping meals regularly) or with a current or planned in the next 7 months specific diet (e.g. hyper or hypocaloric, vegan, vegetarian) or stopped less than 3 months before the study;
  • E15. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator;
  • E16. Smoking more than 10 cigarettes daily or not agreeing to keep his smoking habits unchanged throughout the study. The subject should be able not to smoke the morning and during the visits;
  • E17. Having a lifestyle deemed incompatible with the study according to the investigator including high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded);
  • E18. Who made a blood donation in the 3 months before the randomization or intending to make it within 7 months ahead;
  • E19. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
  • E20. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros;
  • E21. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
  • E22. Presenting a psychological or linguistic incapability to sign the informed consent;
  • E23. Impossible to contact in case of emergency.
  • At V0 biological analysis, the subjects will be considered as non-eligible to the study on the following criteria:
  • E24. Fasting glucose plasma concentration > 126 mg/dL;
  • E25. Blood AST (ASpartate amino Transferase), ALT (ALanine amino Transferase) or GGT (Gamma Glutamyl Transpeptidase) > 3 x ULN (Upper Limit of Normal);
  • E26. TSH (Thyroid Stimulating Hormone) outside the laboratory normal values;
  • E27. Blood urea > 12.11 mmol/L and/or creatinine concentration > 125 μmol/L;
  • E28. Blood hsCRP > 10 mg/L;
  • E29. Complete blood count (CBC) with hemoglobin < 11 g/dL or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

France3 sites

  • Institut Pasteur de Lille

    Lille, 59019

  • Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

    Paris, 75012

  • Biofortis Mérieux NutriSciences

    Saint-Herblain, 44800

Other trials in France

Germany1 site

  • Biotesys

    Esslingen am Neckar, 73728

Other trials in Germany

About this study

Official title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects

This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.

Being tested
TOTUM-070, Placebo
Keywords
Moderate Hypercholesterolemia, Dyslipidemia, Overweight, Obesity, Cardiovascular Risk Factor, Nutrition Healthcare, Plant Extracts, Metabolic diseases, Atherosclerosis, Hygiene and dietary recommendations
Medical subject headings
Hypercholesterolemia, Dyslipidemias, Overweight, Obesity, Atherosclerosis, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOTUM-070Dietary supplement

    Also called Active product

    5-g dose of TOTUM-070 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes

  • PlaceboDietary supplement

    Also called Comparator product

    Placebo. Eight capsules per day to consume orally in two intakes

Study groups in NCT04760951
Study groupRoleWhat they receive
TOTUM-070ExperimentalExperimental active diet supplement TOTUM-070 taken 2 times per day
Receives: Dietary Supplement: TOTUM-070
PlaceboPlacebo comparatorPlacebo comparator taken 2 times per day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting blood LDL cholesterol concentration at V3 with ultracentrifugation method

    Fasting blood LDL concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo

    Measured: V3 (24 weeks of intervention)

Secondary outcomes (22)

  1. Evolution of the fasting blood LDL cholesterol concentration with ultracentrifugation method

    Fasting blood LDL cholesterol concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo

    Measured: V1 (baseline) and V2 (12 weeks of intervention)

  2. Evolution of the fasting blood concentration of triglycerides

    Triglycerides (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  3. Evolution of the fasting blood concentration of total cholesterol

    Total cholesterol (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  4. Evolution of the fasting blood concentration of HDL cholesterol

    HDL cholesterol (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  5. Evolution of the fasting blood concentration of non-HDL cholesterol

    non-HDL cholesterol (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  6. Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)

    LDL cholesterol (in g/L, Friedewald method), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  7. Evolution of the fasting blood concentration of free fatty acids

    Free fatty acids (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  8. Evolution of the fasting blood glycemia

    Glycemia (in mg/dL), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  9. Evolution of the fasting blood hsCRP concentration

    hsCRP (in mg/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  10. Evolution of the fasting blood concentration of apolipoprotein-A1

    Apolipoprotein-A1 (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  11. Evolution of the fasting blood concentration of apolipoprotein-B

    Apolipoprotein-B (in g/L), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  12. Evolution of atherogenic index

    Atherogenic index, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  13. Evolution of atherogenic coefficient

    Atherogenic coefficient, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  14. Evolution of Cardiac risk ratio 1

    Cardiac risk ratio 1, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  15. Evolution of Cardiac risk ratio 2

    Cardiac risk ratio 2, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  16. Evolution of Apo-B/Apo-A1 ratio

    Apo-B/Apo-A1 ratio, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  17. Evolution of the body weight

    Body weight (in kg), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  18. Evolution of the waist circumference

    Waist circumference (in cm), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  19. Evolution of the hip circumference

    Hip circumference (in cm), TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  20. Evolution of the waist to hip ratio

    Waist to hip ratio, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  21. Delay of occurence of pharmacological treatment requirement for hypercholesterolemia from V1

    Delay between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his hypercholesterolemia, TOTUM-070 vs placebo

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

  22. Evolution of the cardiovascular disease risk (SCORE value)

    Systematic Coronary Risk Estimation value from Heartscore calculator

    Measured: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start17 Feb 2021
  3. Primary completion17 Feb 2022
  4. Study completion17 Feb 2022

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760951
Sponsor's protocol ID
PEC20070
Other IDs
2020-A02809-30
Acronym
HEART
Status last verified
Mar 2022
First submitted
16 Feb 2021
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TOTUM-070 in people with Hypercholesterolemia and Cardiovascular Risk Factor, run by Valbiotis at 4 sites in 2 countries.

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 14 inclusion and 30 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France, Germany. 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?

Fasting blood LDL cholesterol concentration at V3 with ultracentrifugation method (time frame: V3 (24 weeks of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760951.

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 29 Mar 2022.

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