Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
Condition: Prediabetes; Type 2 Diabetes; Hypertriglyceridemia; Obesity; Disease; Insulin Resistance
MeSH terms: Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Prediabetic State; Glucose Intolerance; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Given the data on the active ingredients of Totum-63, this research aims to evaluate the
      effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially
      on fasting plasma glucose in volunteers with abdominal obesity associated with impaired
      glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study
      is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several
      glucose and lipid homeostasis related parameters since these data are still unknown for this
      specific dietary supplement formula. Collected data will provide more reliable information
      which may be used to plan a subsequent larger main study.
    

Detailed description: 
      Primary objective:

      The primary objective of the present trial is to assess the beneficial effect of Totum-63
      compared to a placebo on glucose homeostasis assessed by the fasting plasma glucose level in
      prediabetics or untreated type 2 diabetics after 24 weeks of consumption.

      Secondary objectives:

      Secondary objectives of the study are to assess the efficacy of Totum-63 compared to a
      placebo in prediabetics or untreated type 2 diabetics after 12 and 24 weeks of consumption
      through the following criteria:

        -  Glucose homeostasis assessed by fasting plasma glucose level (after 12 weeks of
           consumption only), fasting blood HbA1c and fructosamine levels, OGTT (Oral Glucose
           Tolerance Test after 24 weeks of consumption only), insulinemic and glycemic parameters.

        -  Pancreatic beta-cells function and insulin sensitivity assessed by fasting blood insulin
           level, HOMA-IR (Homeostasis Model Assessment of Insulin Resistance), HOMA-β, QUICKI
           (Quantitative Insulin sensitivity Check Index), ISI-M (Matsuda-DeFronzo Insulin
           Sensitivity Index after 24 weeks of consumption only), OGIS (Oral Glucose Insulin
           Sensitivity after 24 weeks of consumption only) and PREDIM (PREDIcted M after 24 weeks
           of consumption only) indexes.

        -  Lipid homeostasis assessed by fasting blood levels of triglycerides (TG), Total
           Cholesterol (TC), HDL-cholesterol, LDL-cholesterol and NEFA (Non-Esterified Fatty
           Acids).

        -  Oxidation mechanism of circulating lipids assessed by the ratio fasting blood LDLox /
           fasting blood LDLc and the PON-1 (paraoxonase-1, arylesterase activity) activity in
           blood.

        -  Low grade inflammation assessed by fasting blood hsCRP level.

        -  Hepatic function assessed by fasting blood total bilirubin level, GGT, ASAT and ALAT
           activities in blood.

        -  Hemodynamics assessed by Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood
           Pressure (DBP).

        -  Anthropometrics assessed by Body Weight (BW), Waist Circumference (WC), Hip
           Circumference (HC) and Waist to Hip Ratio (WHR).

        -  Satiety assessed by the three-day food diary energy and nutrient intake parameters.

      Safety objectives:

      The following criteria assessed after 24 weeks of study product consumption participate to
      the objectives of safety check:

        -  Renal function assessed by fasting blood creatinine and urea level;

        -  Complete blood count.
    

Intervention name(s): Totum-63; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each randomized subject will consume 8 capsules daily of either active (5200 mg of Totum-63) during 24 weeks (from visit V1 to visit V3). 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.; Each randomized subject will consume 8 capsules daily of placebo (5064 mg of maltodextrine) during 24 weeks (from visit V1 to visit V3). 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