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

NCT05493553 | Completed DMC

• 1 other identifier: BIO-2206
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Impaired Glucose Tolerance

Keywords

Intermittent fasting; Yerba mate; Continuous glucose monitoring; Dietary supplements; Soluble fiber

Outcome Measures

Primary Outcomes (1)

• Glycemic variability

  Within-subject change in glucose coefficient of variation (CV)

  3 days

Secondary Outcomes (6)

• Daytime and Overall Blood Glucose Levels

  3 days

• Daytime glycemic variability

  3 days

• Percent of time in range

  3 days

• Percent of time below range

  3 days

• Percent of time above range

  3 days

Study Arms (3)

Baseline

NO INTERVENTION

A baseline period (no supplements or intermittent fasting).

Phase 1

EXPERIMENTAL

A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals.

Dietary Supplement: Dietary supplement regimen

Phase 2

EXPERIMENTAL

A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals, while also practicing daily intermittent fasting (16 hours fasting, 8 hours eating window).

Other: Dietary supplement and intermittent fasting regimen

Interventions

Dietary supplement regimen DIETARY_SUPPLEMENT

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.

Also known as: Balance, Unimate

Phase 1

Dietary supplement and intermittent fasting regimen OTHER

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.

Also known as: Feel Great

Phase 2

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Unicity International, Inc.: lead
• Biofortis Innovation Services: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Intermittent Fasting

Interventions

diisopropyl sebacate; Dietary Supplements

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dawn Beckman, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Baseline (no supplements or intermittent fasting requirements) and two interventional phases (Phase 1: supplements only; Phase 2: supplements and intermittent fasting)

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 8, 2022
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)