Pre Diabetic Clinical Trial
Official title:
A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Fecal Bacteroidetes: Firmicutes Ratio in Pre-Diabetic Subjects.
| Verified date | July 2014 |
| Source | NuMe Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and satiety.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Healthy male or female. - Stable body weight. - Stable body weight (+ 11 pounds) in the 3 months prior to the study. Between 18 and 70 years of age, inclusive. - BMI between 25 and 45 Kg/m2, inclusive. BMI is a measure of your height to weight ratio. (Body Mass Index). - Fasting blood glucose between 100 and 200 mg/dL, inclusive. Exclusion Criteria: - Pregnant or nursing. - Diabetes or diseases of the liver, pancreas or gastrointestinal tract (except surgery like cholecystectomy, appendectomy or hiatus hernia repair). - Taking a medication for diabetes, or a medication like systemic glucocorticoids that can affect blood insulin, or a mediation like atypical antipsychotics that alters affect blood sugar or blood insulin, or a medication like atypical antipsychotics that alters body weight, or a medication like antibiotics that can change intestinal bacterial flora, or a medication that alters blood lipids. - Past history of Bariatric surgery. - Chronic use of proton pump inhibitors or bulk laxatives. - Active dependence on alcohol (>14 drinks/week) or illegal drugs. - following a weight loss regimen. - Body weight over 350 pounds (.160 kg). - Any chronic medication [for example: for treatment of conditions like hypothyroidism (like thyroxine), gout (like allopurinol) or hypertension (like propranolol)] that has not had a stable dose for 1 month or longer. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| NuMe Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the ratio of Bacteroidetes to Firmicuites ratio in the stool comparing the baseline value to the completion of study value. | Abundance of 11 different genera that are characterized in lean and obese individuals will be quantitated and the ratio of abundance of those in the Bacteriodetes phylum to Firmicutes phylum will calculated. | 4 weeks | No |
| Secondary | Insulin sensitivity based on homeostasis model assessment (HOMA) | Fasting blood glucose and insulin levels will be used to calculate HOMA-IR (insulin resistance) and to estimate insulin sensitivity at baseline and at the completion of the study. | 4 weeks | No |
| Secondary | Fasting blood glucose | Weekly measurements of fasting blood glucose and serum insulin will be performed. | Weekly for 4 weeks | No |
| Secondary | Body weight | Body weight will be monitored weekly. | Weekly for 4 weeks | No |
| Secondary | Hunger perception | Visual analog scales to assess appetite and satiety will be used at weekly visits. | Weekly for 4 weeks | No |
| Secondary | Meal tolerance test | A fixed meal will be consumed at 3 weeks. Visual analog scales (VAS) for appetite will be used to measure hunger before the meal. A VAS to assess satiety will be used at completion of the meal. Plasma ghrelin, PYY, GLP-1, glucose and insulin will be measured both before the meal and at 1 hour after consumption. | 3 weeks | No |
| Secondary | Clinical Chemistry | Blood will be obtained at baseline and after 4-weeks of treatment to measure lipids, high-sensitivity C-reactive protein (hsCRP) and glycosylated hemoglobin (HgbA1c). | 4 weeks | No |
| Secondary | Fecal profiling | Feces will be collected at baseline and after 4 weeks to measure pH, short chain fatty acids, pathogens, branched chain fatty acids and triglycerides to assess changes in the GI microbiome. | 4 weeks | No |
| Secondary | Insulin sensitivity based on Oral Glucose Tolerance Testing | An oral glucose tolerance test will be performed at baseline and at the completion of the study to estimate insulin sensitivity. | 4 weeks | No |
| Secondary | Mood | A standardized mood instrument will be used at baseline and at 4 weeks. | 4 weeks | No |
| Secondary | Gastrointestinal Symptoms | A survey to measure GI symptoms, changes in bowel habits and changes in stool characteristics will be performed on weekly visits for 4 weeks. | 4 weeks | No |