Status:
COMPLETED
Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes
Lead Sponsor:
Zhaoping Li
Conditions:
PreDiabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition, the study also...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04428606
Start Date
April 1 2021
End Date
June 1 2022
Last Update
June 16 2022
Active Locations (1)
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1
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States, 90095