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

NCT05493553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-11-01

No results posted yet for this study

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.

Conditions

  • Healthy
  • Impaired Glucose Tolerance

Interventions

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.

Sponsors & Collaborators

  • Biofortis Innovation Services

    collaborator INDUSTRY

  • Unicity International, Inc.

    lead INDUSTRY

Principal Investigators

  • Dawn Beckman, MD · Biofortis Innovation Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2022-09-29
Completion
2022-09-29

Countries

  • United States

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 NCT05493553 on ClinicalTrials.gov