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

Zhaoping Li

Status: Completed

Conditions: PreDiabetes

Treatments: Dietary Supplement: Butyrate Ultra; Dietary Supplement: Placebo; Dietary Supplement: Metabolic Rheostat

Study type: Interventional

Funder types: Other

Identifiers

NCT04428606

20-000879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Metabolic Rheostat™

Experimental group

Description:

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

Treatment:

Dietary Supplement: Metabolic Rheostat

Butyrate Ultra

Experimental group

Description:

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

Treatment:

Dietary Supplement: Butyrate Ultra

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo