MedTrace Logo

Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

NCT02989753 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-05

No results posted yet for this study

Summary

This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.

Conditions

Interventions

DIETARY_SUPPLEMENT

VAL070-A

After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

DIETARY_SUPPLEMENT

VAL070-B

After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

DIETARY_SUPPLEMENT

Placebo

After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • David GENDRE, Dr · Biofortis Mérieux NutriSciences

  • Jean-Marie BARD, Dr-PhD · UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France

  • Sébastien PELTIER, PhD · Valbiotis

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
2017-01-31
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • France

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 NCT02989753 on ClinicalTrials.gov