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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Unicity International, Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Glycemic variability
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) ≥25.0 to \<35.0 kg/m2
- •At least 1 out of the 3 following criteria:
- •Waist circumference \>102 cm for men and \>88 cm for women
- •Family history of at least one parent or sibling with diagnosed impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM)
- •Sedentary lifestyle (based on self-report)
Exclusion Criteria
- •Fasting glucose ≥126 mg/dL or diagnosed with diabetes mellitus (type 1 or 2).
- •Uncontrolled and/or clinically important pulmonary, hepatic, renal, cardiac, hematologic, immunologic, neurologic, psychiatric or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- •Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- •History of or current diagnosis of conditions that may affect blood glucose levels.
- •Any known food allergy as well as intolerance or sensitivity to study product ingredients and caffeine.
- •Any extreme diets or history of eating disorders that in the opinion of the Clinical Investigator that may affect the study outcomes or the subject's ability to adhere to the study program.
- •Weight loss or gain \> 4.5 kg within 90 days of Visit
- •Currently or planning to be on a weight loss or weight gain / muscle-building regimen program during the study.
- •Major trauma or any other surgical event within 90 days of Visit
- •History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
Outcomes
Primary Outcomes
Glycemic variability
Time Frame: 3 days
Within-subject change in glucose coefficient of variation (CV)
Secondary Outcomes
- Daytime and Overall Blood Glucose Levels(3 days)
- Percent of time below range(3 days)
- Percent of time above range(3 days)
- Gastrointestinal symptoms(2 weeks)
- Daytime glycemic variability(3 days)
- Percent of time in range(3 days)