- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760951
Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects (HEART)
March 28, 2022 updated by: Valbiotis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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).
Exclusion Criteria:
- 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);
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TOTUM-070
Experimental active diet supplement TOTUM-070 taken 2 times per day
|
5-g dose of TOTUM-070 diet supplement, a mix of 5 plant extracts.
Eight capsules per day to consume orally in two intakes
Other Names:
|
Placebo Comparator: Placebo
Placebo comparator taken 2 times per day
|
Placebo.
Eight capsules per day to consume orally in two intakes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting blood LDL cholesterol concentration at V3 with ultracentrifugation method
Time Frame: V3 (24 weeks of intervention)
|
Fasting blood LDL concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo
|
V3 (24 weeks of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of the fasting blood LDL cholesterol concentration with ultracentrifugation method
Time Frame: V1 (baseline) and V2 (12 weeks of intervention)
|
Fasting blood LDL cholesterol concentration (in g/L) with ultracentrifugation method, TOTUM-070 vs placebo
|
V1 (baseline) and V2 (12 weeks of intervention)
|
Evolution of the fasting blood concentration of triglycerides
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Triglycerides (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of total cholesterol
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Total cholesterol (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of HDL cholesterol
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
HDL cholesterol (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of non-HDL cholesterol
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
non-HDL cholesterol (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of LDL cholesterol (Friedewald method)
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
LDL cholesterol (in g/L, Friedewald method), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of free fatty acids
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Free fatty acids (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood glycemia
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Glycemia (in mg/dL), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood hsCRP concentration
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
hsCRP (in mg/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of apolipoprotein-A1
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Apolipoprotein-A1 (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the fasting blood concentration of apolipoprotein-B
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Apolipoprotein-B (in g/L), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of atherogenic index
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Atherogenic index, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of atherogenic coefficient
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Atherogenic coefficient, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of Cardiac risk ratio 1
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Cardiac risk ratio 1, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of Cardiac risk ratio 2
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Cardiac risk ratio 2, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of Apo-B/Apo-A1 ratio
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Apo-B/Apo-A1 ratio, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the body weight
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Body weight (in kg), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the waist circumference
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Waist circumference (in cm), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the hip circumference
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Hip circumference (in cm), TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the waist to hip ratio
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Waist to hip ratio, TOTUM-070 vs placebo
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Delay of occurence of pharmacological treatment requirement for hypercholesterolemia from V1
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
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
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Evolution of the cardiovascular disease risk (SCORE value)
Time Frame: V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Systematic Coronary Risk Estimation value from Heartscore calculator
|
V1 (baseline), V2 (12 weeks of intervention) and V3 (24 weeks of intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Isabelle METREAU, MD, Biofortis Mérieux NutriSciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2021
Primary Completion (Actual)
February 17, 2022
Study Completion (Actual)
February 17, 2022
Study Registration Dates
First Submitted
February 16, 2021
First Submitted That Met QC Criteria
February 16, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEC20070
- 2020-A02809-30 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atherosclerosis
-
University Hospital, CaenUnknownPeripheral Arterial Disease | Atherosclerosis Obliterans | Atherosclerosis Right Leg | Atherosclerosis Left LegFrance
-
Nantes University HospitalAbbottCompletedAtherosclerosis ObliteransFrance
-
Central Hospital, Nancy, FranceSuspended
-
Federal University of São PauloCompletedAtherosclerosis of ArteryBrazil
-
MedtronicActive, not recruitingAtherosclerosis of Femoral Artery | Obstructive Disease | Atherosclerosis of Popliteal ArteryFrance
-
Cabinet de Medecine Interne Générale Demetrio PitarchCompletedAtherosclerosis of Artery
-
Emory UniversityThe Robert W. Woodruff FoundationCompleted
-
Korea UniversityMinistry of Health & Welfare, KoreaCompletedAtherosclerosis | Noninvasive Imaging of AtherosclerosisKorea, Republic of
-
Zhejiang Zylox Medical Device Co., Ltd.RecruitingAtherosclerosis of Femoral ArteryGermany
-
VA Office of Research and DevelopmentCompletedSaphenous Vein Graft AtherosclerosisUnited States
Clinical Trials on TOTUM-070
-
ValbiotisUniversity Hospital, Clermont-FerrandTerminatedAtherosclerosis | Dyslipidemias | Hypercholesterolemia | Cardiovascular Risk Factor | Cardio-metabolic RiskFrance
-
ValbiotisRecruiting
-
Selecta Biosciences, Inc.Completed
-
ValbiotisUniversity Hospital, Clermont-Ferrand; Clinic'n'CellRecruitingNAFLD | MASLD | Mild Inflammatory ContextFrance
-
ValbiotisLaval University; Centre de Recherche de l'Institut Universitaire de Cardiologie... and other collaboratorsRecruitingPrediabetic State | Overweight and Obesity | DysglycemiaCanada
-
IDEA AGCompleted
-
ValbiotisInstitut Pasteur de Lille; Biofortis Mérieux NutriSciencesCompletedObesity | Disease | Insulin Resistance | Type 2 Diabetes | Hypertriglyceridemia | PrediabetesFrance, Ireland, Serbia, Slovenia
-
ValbiotisExcelyaActive, not recruitingMetabolic Syndrome | Prehypertension | Blood Pressure | Elevated Blood PressurePoland, Bulgaria, France
-
ValbiotisBioTeSys GmbHRecruitingElevated Blood PressureGermany
-
ValbiotisBiofortis Mérieux NutriSciencesCompletedDiabetes type2 | Prediabetic State | DysglycemiaItaly, France, Germany, Poland, Romania, Bulgaria, Hungary