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

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metabolic Rheostat
Butyrate Ultra
Placebo
Sponsored by
Zhaoping Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PreDiabetes focused on measuring glucose control, microbiome, prediabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCLA Center for Human Nutrition, 1000 Veteran Ave.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Metabolic Rheostat™

Butyrate Ultra

Placebo

Arm Description

Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days.

Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days.

Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
May 13, 2020
Last Updated
June 15, 2022
Sponsor
Zhaoping Li
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1. Study Identification

Unique Protocol Identification Number
NCT04428606
Brief Title
Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes
Acronym
Rheostat
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhaoping Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
glucose control, microbiome, prediabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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 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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metabolic Rheostat™
Arm Type
Experimental
Arm Description
Participants will take 6 capsules of Rheostat daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Arm Title
Butyrate Ultra
Arm Type
Experimental
Arm Description
Participants will take 6 capsules Butyrate Ultra daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take 6 capsules of placebo daily, two capsules three times per day 30 minutes prior to each meal for 56 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Metabolic Rheostat
Intervention Description
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Butyrate Ultra
Intervention Description
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra
Description
Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Metabolic impact of Metabolic Rheostat and Butyrate Ultra
Description
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.
Time Frame
8 weeks
Title
Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UCLA Center for Human Nutrition, 1000 Veteran Ave.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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