Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes (Rheostat)
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ClinicalTrials.gov Identifier: NCT04428606 |
Recruitment Status :
Completed
First Posted : June 11, 2020
Last Update Posted : June 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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PreDiabetes | Dietary Supplement: Metabolic Rheostat Dietary Supplement: Butyrate Ultra Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ 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 Rheostat™; 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. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Other |
Official Title: | Placebo Controlled Pilot Trial to Determine the Effect of Metabolic Rheostat™ and Butyrate Ultra on Hemoglobin A1C and Blood Glucose Levels in Patients With Pre-diabetes |
Actual Study Start Date : | April 1, 2021 |
Actual Primary Completion Date : | March 30, 2022 |
Actual Study Completion Date : | June 1, 2022 |

Arm | Intervention/treatment |
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Experimental: Metabolic Rheostat™
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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Dietary Supplement: Metabolic Rheostat
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder |
Experimental: Butyrate Ultra
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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Dietary Supplement: Butyrate Ultra
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance. |
Placebo Comparator: Placebo
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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Dietary Supplement: Placebo
Placebo |
- Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra [ Time Frame: 2 hours ]Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.
- Metabolic impact of Metabolic Rheostat and Butyrate Ultra [ Time Frame: 8 weeks ]Determining the effects of Metabolic Rheostat™ and Butyrate Ultra on gut hormones/incretins (including insulin, C-peptide, glucagon, CCK, GLP-1, GIP, and PYY) using Luminex bead-based technology.
- Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings [ Time Frame: 8 weeks ]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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male and female subjects with pre-diabetes.
- Age> 18 years
- Ability to understand and the willingness to sign a written informed consent.
- Willing and able to comply with trial protocol and follow-up.
Exclusion Criteria:
- Current use of any other investigational agent.
- Current use of any agent for treatment of diabetes.
- History of adverse effects, intolerance, or allergic reactions attributed to any medications.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Abnormal blood analysis for complete blood count (CBC), hepatic and renal injury tests.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428606
United States, California | |
UCLA Center for Human Nutrition, 1000 Veteran Ave. | |
Los Angeles, California, United States, 90095 |
Responsible Party: | Zhaoping Li, Chief / Professor of Medicine, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT04428606 |
Other Study ID Numbers: |
20-000879 |
First Posted: | June 11, 2020 Key Record Dates |
Last Update Posted: | June 16, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
glucose control microbiome prediabetes |
Prediabetic State Glucose Intolerance Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |