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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493553
• Other study ID #: BIO-2206
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: October 2022
• Source: Unicity International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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 1.
• 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 1.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Unstable use of hormonal contraceptives (change in medication regimen within 90 days of Visit 1).
• Unstable use of medications that affect blood glucose levels whereby stable is defined as no change in regimen within 90 days of Visit 1.
• Use of oral or injectable steroids (topical and inhaled are allowed) within 90 days of Visit 1
• Use of fiber supplements or intentionally increasing fiber intake within 30 days of Visit 1
• Use of yerba mate containing products (beverage, supplement) within 30 days of Visit 1
• Exposure to any non-registered drug product within 30 days prior to Visit 1
• Use of vitamin C-containing supplements (including multivitamins) within 24 hours of Visit 2 and during the study intervention period.
• Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the sensor) within 24 hours of Visit 2 and during the study intervention period.
• Use of topical marijuana or hemp products within 24 hours of Visit 2 and during the study intervention period.
• Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception during the study period.
• Recent history (within 12 months) of alcohol or substance abuse.
• Has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Related Conditions & MeSH terms

• Glucose Intolerance
• Healthy
• Impaired Glucose Tolerance

Intervention

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.

Locations

Country	Name	City	State
United States	Biofortis Clinical Research	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Unicity International, Inc.	Biofortis Innovation Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variability	Within-subject change in glucose coefficient of variation (CV)	3 days
Secondary	Daytime and Overall Blood Glucose Levels	Daytime (6 am - 11:59 pm), Overall (24 hours)	3 days
Secondary	Daytime glycemic variability	Coefficient of variation (CV) of glucose values during daytime hours (6 am - 11:59 pm)	3 days
Secondary	Percent of time in range	70-140 mg/dL	3 days
Secondary	Percent of time below range	< 70 mg/dL	3 days
Secondary	Percent of time above range	> 140 mg/dL	3 days
Secondary	Gastrointestinal symptoms	Daily gastrointestinal tolerance questionnaire	2 weeks