A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome

Completed · Not applicable · Has a placebo group

Conditions studied: Pre Diabetic

In brief

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.

Key facts

Study ID

NCT01724736

Run by

NuMe Health

People needed

45

Starts

2012-11-01

Expected to finish

2014-02-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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