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

NCT04760951 | Completed DMC

• 2 other identifiers: PEC200702020-A02809-30
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 4

Brief 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 method) after 24 weeks of consumption.

Conditions

Hypercholesterolemia; Cardiovascular Risk Factor; Dyslipidemias; Overweight and Obesity; Atherosclerosis

Keywords

Moderate Hypercholesterolemia; Dyslipidemia; Overweight; Obesity; Cardiovascular Risk Factor; Nutrition Healthcare; Plant Extracts; Metabolic diseases; Atherosclerosis; Hygiene and dietary recommendations

Outcome Measures

Primary Outcomes (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

  V3 (24 weeks of intervention)

Secondary Outcomes (22)

• Evolution of the fasting blood LDL cholesterol concentration with ultracentrifugation method

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

• Evolution of the fasting blood concentration of triglycerides

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

• Evolution of the fasting blood concentration of total cholesterol

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

• Evolution of the fasting blood concentration of HDL cholesterol

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

• Evolution of the fasting blood concentration of non-HDL cholesterol

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

Study Arms (2)

TOTUM-070

EXPERIMENTAL

Experimental active diet supplement TOTUM-070 taken 2 times per day

Dietary Supplement: TOTUM-070

Placebo

PLACEBO COMPARATOR

Placebo comparator taken 2 times per day

Dietary Supplement: Placebo

Interventions

TOTUM-070 DIETARY_SUPPLEMENT

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

Also known as: Active product

TOTUM-070

Placebo DIETARY_SUPPLEMENT

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

Also known as: Comparator product

Placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Valbiotis: lead
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (4)

Institut Pasteur de Lille

Lille, 59019, France

Location

Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

Paris, 75012, France

Location

Biofortis Mérieux NutriSciences

Saint-Herblain, 44800, France

Location

Biotesys

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias; Overweight; Obesity; Atherosclerosis; Metabolic Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Isabelle Metreau, MD

  Biofortis Mérieux NutriSciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 2 blinded arms (Active and Placebo)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 18, 2021
• Study Start: February 17, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); DE (1)