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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PreDiabetes

Intervention / Treatment
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* Dietary Supplement: Metabolic Rheostat
* Dietary Supplement: Butyrate Ultra
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic Rheostat™<br>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<br>* Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder<br>|
| Experimental: Butyrate Ultra<br>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<br>* An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.<br>|
| Placebo Comparator: Placebo<br>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<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose control, microbiome, prediabetes