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Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes

About

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 aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
20-000879
Category
Center for Human Nutrition
Contact
Gail Thames
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04428606
For detailed technical eligibility, visit ClinicalTrials.gov.