NCT02868177

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

Totum-63 Effect on Glucose and Lipid Homeostasis in People With Abdominal Obesity Associated With Impaired Glucose Tolerance or Untreated Type 2 Diabetes and Hypertriglyceridemia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Valbiotis · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-08-16
• Last updated: 2020-10-05

Locations

6 sites across 4 countries: France, Ireland, Serbia, Slovenia