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

NCT04428606 | Completed

• 1 other identifier: 20-000879
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

glucose control; microbiome; prediabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Metabolic impact of Metabolic Rheostat and Butyrate Ultra

  8 weeks

• Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings

  8 weeks

Study Arms (3)

Metabolic Rheostat™

EXPERIMENTAL

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

Butyrate Ultra

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Metabolic Rheostat DIETARY_SUPPLEMENT

Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder

Metabolic Rheostat™

Butyrate Ultra DIETARY_SUPPLEMENT

An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.

Butyrate Ultra

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhaoping Li: lead

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief / Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 11, 2020
• Study Start: April 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 1, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (1)