Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

NCT06243484 | Active Not Recruiting

• 2 other identifiers: VCT-013BTS1876_22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Evolution of fasting blood LDL cholesterol level

  Fasting blood LDL cholesterol level by Ultracentrifugation method

  Baseline (V1) and End of consumption after 12 weeks (V3)

Secondary Outcomes (10)

• Evolution of fasting blood LDL cholesterol level

  Baseline (V1), Following 6 weeks of consumption (V2) and 6 weeks after the end of consumption (V4)

• Evolution of Lipid profile

  Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)

• Evolution of Lipid homeostasis indices

  Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)

• Evolution of fasting glycemia

  Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)

• Evolution of Low grade inflammation

  Baseline (V1), Following 6 weeks of consumption (V2), at the end of consumption after 12 weeks (V3) and 6 weeks after the end of consumption (V4)

Study Arms (2)

TOTUM-070

EXPERIMENTAL

The experimental arm will be supplemented with TOTUM-070 twice a day

Dietary Supplement: TOTUM-070

PLACEBO

PLACEBO COMPARATOR

The placebo comparator arm will be supplemented with a placebo twice a day

Dietary Supplement: PLACEBO

Interventions

TOTUM-070 DIETARY_SUPPLEMENT

12 weeks of TOTUM-070 supplementation with Placebo (blinded arms)

Also known as: Active product 2 intakes per day

TOTUM-070

PLACEBO DIETARY_SUPPLEMENT

8 capsules per day to consume orally in two intakes

Also known as: Comparator product 2 intakes per day

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. BMI of ≥18.5 and ≤35 kg/m²;
• I3. Moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment;
• I4. Weight stable within ± 5% in the last three months before V0;
• I5. SCORE2 - SCORE2-OP (Older Persons) Cardiovascular Risk Chart

You may not qualify if:

• E1. Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
• E2. Suffering from an uncontrolled arterial hypertension;
• E3. With a history of ischemic cardiovascular event;
• E4. Having undergone recent surgical procedure in the past 6 months before V0 or planned in the 5 months to come;
• E5. History of bariatric surgery;
• E6. Suffering from a severe chronic disease;
• E7. For women: ongoing pregnancy (as evidenced by a positive test for β-Human Chorionic Gonadotropin, i.e. \> 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months before V0 or intending to become pregnant within 5 months ahead;
• E10. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women

Sponsors & Collaborators

• Valbiotis: lead

Study Sites (1)

Biotesys

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Daniel Menzel, MD

  Biotesys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted in a double-blind randomized manner. The random allocation sequence will be provided sealed to the independent pharmacist (not involved in the study) by an independent statistician. The ratio of randomization between the verum and placebo groups will be 1:1. Stratification randomization will be performed according to LDL-c at V0 (\<160 mg/dL / ≥ 160 mg/dL) and site.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: October 4, 2023
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)