NCT05493553

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Unicity International, Inc. · Industry
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary supplement regimen	The powdered, soluble fiber-based supplement contains soluble fibers, phytosterols, plant-derived polysaccharides, flavor, maltodextrin, orange juice powder, citric acid, vitamin and mineral blend, and sweetener. This is prepared in water and consumed twice per day, prior to a meal. The yerba mate-based supplement (containing green yerba mate leaf extract, sweeteners, and flavor) is a powdered supplement prepared in water and consumed in the morning.
OTHER	Dietary supplement and intermittent fasting regimen	The dietary supplement regimen is the same as in Phase 1. The intermittent fasting protocol consists of a 16-hour fasting period and an 8-hour eating window.

Timeline

• Start date: 2022-08-08
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2022-08-09
• Last updated: 2022-11-01

Locations

1 site across 1 country: United States