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The aim of this study is to examine the effect of Metabolic Rheostatâ„¢ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition, the study also aims to look at the effect of Metabolic Rheostatâ„¢ and Butyrate Ultra on weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.
This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostatâ„¢ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The entire study will last 10 weeks including screen. The study will include 20 subjects with prediabetes treated with Metabolic Rheostatâ„¢; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic Rheostatâ„¢ | Experimental | Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days. |
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| Butyrate Ultra | Experimental | Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days. |
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| Placebo | Placebo Comparator | Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolic Rheostat | Dietary Supplement | Metabolic Rheostatâ„¢ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra | Determine the effect of Metabolic Rheostatâ„¢ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic impact of Metabolic Rheostat and Butyrate Ultra | Determining the effects of Metabolic Rheostatâ„¢ and Butyrate Ultra on gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) using Luminex bead-based technology. | 8 weeks |
| Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Human Nutrition, 1000 Veteran Ave. | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostatâ„¢ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The study will include 20 subjects with prediabetes treated with Metabolic Rheostatâ„¢; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
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| Butyrate Ultra | Dietary Supplement | An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance. |
|
| Placebo | Dietary Supplement | Placebo |
|
Exploratory of Food Addiction (FA) using the Yale Food Addiction Scale (0 symptoms to 11 symptoms). Scale indications are: mild = 2-3 symptoms plus impairment or distress, moderate = 4-5 symptoms plus impairment or distress, severe = 6 or more symptoms plus impairment or distress). |
| 8 weeks |
| D004700 | Endocrine System Diseases |