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

NCT04760951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

TOTUM-070

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • Isabelle Metreau, MD · Biofortis Mérieux NutriSciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2022-02-17
Completion
2022-02-17

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760951 on ClinicalTrials.gov