NCT02989753

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

Pilot Study to Assess Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Valbiotis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Main objective The primary objective of the present trial is to assess the beneficial effect of VAL070-B compared to a placebo, on blood LDL cholesterol level in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks of consumption. Secondary objectives Secondary objectives of the study are to assess the effects of VAL070-A and VAL070-B, compared to a placebo and to each other, in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks if consumption through the following parameters: * Blood level of LDL cholesterol (VAL070-A compared to placebo and VAL070-A compared to VAL070-B), * Lipid profile: Blood levels of triglycerides, total cholesterol, HDL-cholesterol and non- HDL cholesterol, * Glycaemia, * Blood hsCRP, * Fructosamine, * Blood total free fatty acid levels, * Anthropometrics assessed by body weight (BW), waist circumference (WC), hip circumference (HC) and waist to hip ratio (WHR). Safety objectives The following parameters, analyzed at baseline and after 12 weeks of consumption, participated to the safety objectives: * Blood levels of urea and creatinine, * Blood levels of GGT, AST and ALT, * Complete blood count, * Hemodynamic measurements: heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), * Adverse events.

Conditions

• Hypercholesterolemia
• Hypertriglyceridemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2016-12-12
• Last updated: 2018-07-05

Locations

1 site across 1 country: France