Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes

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.

Conditions

• Prediabetes
• Type 2 Diabetes
• Hypertriglyceridemia
• Obesity
• Disease
• Insulin Resistance

Interventions

DIETARY_SUPPLEMENT

Totum-63

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

• Biofortis Mérieux NutriSciences

  collaborator OTHER

• Institut Pasteur de Lille

  collaborator OTHER

• Valbiotis

  lead INDUSTRY

Principal Investigators

• David GENDRE, Dr · Biofortis Mérieux NutriSciences

• Sébastien L PELTIER, PhD · Valbiotis

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2019-04-30

Completion

2019-04-30

Countries

• France
• Ireland
• Serbia
• Slovenia

Study Locations