Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes
NCT ID: NCT04428606
Last Updated: 2022-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-04-01
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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.
Metabolic Rheostat
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
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.
Butyrate Ultra
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
Placebo
Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Placebo
Placebo
Interventions
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Metabolic Rheostat
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
Butyrate Ultra
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Age\> 18 years
3. Ability to understand and the willingness to sign a written informed consent.
4. Willing and able to comply with trial protocol and follow-up.
Exclusion Criteria
2. Current use of any agent for treatment of diabetes.
3. History of adverse effects, intolerance, or allergic reactions attributed to any medications.
4. 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.
5. Abnormal blood analysis for complete blood count (CBC), hepatic and renal injury tests.
18 Years
ALL
Yes
Sponsors
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Zhaoping Li
OTHER
Responsible Party
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Zhaoping Li
Chief / Professor of Medicine
Locations
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UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States
Countries
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Other Identifiers
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20-000879
Identifier Type: -
Identifier Source: org_study_id
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