Clinical trial NCT04428606: Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: glucose control
microbiome
prediabetes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra
timeFrame: 2 hours
Secondary outcomes:
measure: Metabolic impact of Metabolic Rheostat and Butyrate Ultra
timeFrame: 8 weeks
measure: Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, 1000 Veteran Ave.
state: California
Study officials:
References: