Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2025-04-30

Brief Summary

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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).

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Detailed Description

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The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).

The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLINDED STUDY

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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TOTUM-070

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

Group Type EXPERIMENTAL

TOTUM-070

Intervention Type DIETARY_SUPPLEMENT

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

PLACEBO

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

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DIETARY_SUPPLEMENT

8 capsules per day to consume orally in two intakes

Interventions

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TOTUM-070

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

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

8 capsules per day to consume orally in two intakes

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Active product 2 intakes per day Comparator product 2 intakes per day

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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;
* E8. Under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit V0;
* E9. Under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
* E10. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes