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

Zhaoping Li60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

PreDiabetes

Interventions

Metabolic RheostatDIETARY_SUPPLEMENT

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

Butyrate UltraDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 hours

Secondary Outcomes

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.

Time frame: 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).

Time frame: 8 weeks

Data from ClinicalTrials.gov

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