PreDiabetes
Conditions
Keywords
glucose control, microbiome, prediabetes
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.
Interventions
DIETARY_SUPPLEMENTMetabolic Rheostat
Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
DIETARY_SUPPLEMENTButyrate Ultra
An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Zhaoping Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose effects of dietary supplement: Metabolic Rheostat vs. Butyrate Ultra | 2 hours | Determine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with pre-diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic impact of Metabolic Rheostat and Butyrate Ultra | 8 weeks | 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. |
| Impact of Metabolic Rheostat and Butyrate Ultra on food addiction and cravings | 8 weeks | 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). |
Countries
United States
Outcome results
None listed