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

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.

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.