NCT04423302

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

Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: Valbiotis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-07-08
• Primary completion: 2023-01-31
• Completion: 2023-06-23
• First posted: 2020-06-09
• Last updated: 2023-09-21

Locations

52 sites across 7 countries: Bulgaria, France, Germany, Hungary, Italy, Poland, Romania