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

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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Metabolic Rheostat; Dietary supplement: Butyrate Ultra

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Metabolic Rheostat; Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
Experimental: 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.	Dietary supplement: Butyrate Ultra; An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
Placebo Comparator: Placebo; Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra	Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic impact of Metabolic Rheostat and Butyrate Ultra	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.	8 weeks
Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings	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).	8 weeks

Collaborators and Investigators

• Sponsor: Zhaoping Li

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: glucose control; microbiome; prediabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 20-000879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No