Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability

Healthy Clinical Trial

Official title: Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability and Glycemic Control in Men and Women With Risk Factors for Impaired Fasting Glucose: A Sub-chronic Continuous Glucose Monitoring Pilot Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the short-term effect of a nutritional program consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic variability in men and women with risk factors for impaired fasting glucose.

Clinical Trial Description

The purpose of this study is to determine the effect of a nutritional program which combines two different supplements (a yerba mate extract supplement and a fiber-based, vitamin-rich nutritional supplement) and intermittent fasting on glycemic variability and glycemic control in men and women with risk factors for impaired fasting glucose.

This study will be an exploratory pilot study with one screening visit, one baseline visit followed by a baseline phase, two intervention phases, and one follow-up visit. During the baseline phase, subjects will follow their regular dietary routines. During the 4-day Phase 1, subjects will take the yerba mate supplement once per day and the fiber supplement twice per day. During the 4-day Phase 2, subjects will continue the supplement regimen from Phase 1, while incorporating daily intermittent fasting for approximately 16 hours and eating for 8 hours. A continuous glucose monitor will be worn by each subject to continuously measure glucose throughout the study period. ;

Related Conditions & MeSH terms

• Glucose Intolerance
• Healthy
• Impaired Glucose Tolerance

• NCT number: NCT05493553
• Study type: Interventional
• Source: Unicity International, Inc.
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Completion date: September 29, 2022