Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia
Condition: Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hypercholesterolemia; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): VAL070-A; VAL070-B; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention