NCT06243484

Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

Clinical Study to Investigate the Effect of the Food Supplement TOTUM-070 on Lipid Metabolism in Moderately Hypercholesterolemic Subjects After 3 Months of Supplementation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Valbiotis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Detailed description

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

• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TOTUM-070	12 weeks of TOTUM-070 supplementation with Placebo (blinded arms)
DIETARY_SUPPLEMENT	PLACEBO	8 capsules per day to consume orally in two intakes

Timeline

• Start date: 2023-10-04
• Primary completion: 2025-01-31
• Completion: 2025-04-30
• First posted: 2024-02-06
• Last updated: 2024-07-01

Locations

1 site across 1 country: Germany