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

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ClinicalTrials.gov Identifier: NCT04428606
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
PreDiabetes Dietary Supplement: Metabolic Rheostat Dietary Supplement: Butyrate Ultra Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra [ Time Frame: 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 :
  1. Metabolic impact of Metabolic Rheostat and Butyrate Ultra [ Time Frame: 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.

  2. Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428606


Contacts
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Contact: Gail Thames 310-825-0453 Gthames@mednet.ucla.edu
Contact: Jeraldine Guzman 310-206-8292 jbguzman@mednet.ucla.edu

Locations
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United States, California
UCLA Center for Human Nutrition, 1000 Veteran Ave. Recruiting
Los Angeles, California, United States, 90095
Contact: Gail Thames    310-825-0453    gthames@mednet.ucla.edu   
Contact: Jeraldine Guzman    310-206-8292    jbguzamn@mednet.ucla.edu   
Principal Investigator: Zhaoping Li         
Sponsors and Collaborators
Zhaoping Li
More Information
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Responsible Party: Zhaoping Li, Chief / Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04428606    
Other Study ID Numbers: 20-000879
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
glucose control
microbiome
prediabetes
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia