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| Name | Class |
|---|---|
| Biofortis Innovation Services | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | Within-subject change in glucose coefficient of variation (CV) | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime and Overall Blood Glucose Levels | Daytime (6 am - 11:59 pm), Overall (24 hours) | 3 days |
| Daytime glycemic variability | Coefficient of variation (CV) of glucose values during daytime hours (6 am - 11:59 pm) |
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Inclusion Criteria:
At least 1 out of the 3 following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Beckman, MD | Biofortis Innovation Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C050859 | diisopropyl sebacate |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Baseline (no supplements or intermittent fasting requirements) and two interventional phases (Phase 1: supplements only; Phase 2: supplements and intermittent fasting)
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| 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. |
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| 3 days |
| Percent of time in range | 70-140 mg/dL | 3 days |
| Percent of time below range | < 70 mg/dL | 3 days |
| Percent of time above range | > 140 mg/dL | 3 days |
| Gastrointestinal symptoms | Daily gastrointestinal tolerance questionnaire | 2 weeks |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |