Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Zhaoping Li (ucla)

Description

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.

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

Details

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 entire study will last 10 weeks including screen. 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.

Keywords

PreDiabetes glucose control microbiome Prediabetic State Glucose Intolerance Metabolic Rheostat Butyrate Ultra Metabolic Rheostat™

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male and female subjects with pre-diabetes.
  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.

You CAN'T join if...

  1. Current use of any other investigational agent.
  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.

Location

  • UCLA Center for Human Nutrition, 1000 Veteran Ave. accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zhaoping Li
ID
NCT04428606
Study Type
Interventional
Last Updated