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

PreDiabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04428606
• Other study ID #: 20-000879
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition, 1000 Veteran Ave.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoping Li

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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