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Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)

NCT04423302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2023-09-21

No results posted yet for this study

Summary

This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.

Conditions

  • Prediabetic State
  • Diabetes type2
  • Dysglycemia

Interventions

DIETARY_SUPPLEMENT

TOTUM-63 3 intakes per day

5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)

DIETARY_SUPPLEMENT

Placebo 3 intakes per day

Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)

DIETARY_SUPPLEMENT

TOTUM-63 2 intakes per day

5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • Isabelle METREAU, MD · Biofortis Mérieux NutriSciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2023-01-31
Completion
2023-06-23

Countries

  • Bulgaria
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423302 on ClinicalTrials.gov