Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes
- Conditions
- PreDiabetes
- Interventions
- Dietary Supplement: Metabolic RheostatDietary Supplement: Butyrate UltraDietary Supplement: Placebo
- Registration Number
- NCT04428606
- Lead Sponsor
- Zhaoping Li
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metabolic Rheostat™ 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. Butyrate Ultra 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. Placebo Placebo Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
- Primary Outcome Measures
Name Time Method Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra 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.
- Secondary Outcome Measures
Name Time Method Metabolic impact of Metabolic Rheostat and Butyrate Ultra 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 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).
Trial Locations
- Locations (1)
UCLA Center for Human Nutrition, 1000 Veteran Ave.
🇺🇸Los Angeles, California, United States