Clinical trial NCT01724736: A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Gastrointestinal Microbiome
Official title: A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Fecal Bacteroidetes: Firmicutes Ratio in Pre-Diabetic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetic
Keywords: microbiome
prebiotic
cobiotic
NM504
GI microbiome
Lead sponsor: NuMe Health
Sponsor class: INDUSTRY
First posted: 2012-11-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Human gut microbiome appears to be involved in the regulation of metabolic processes, including digested food components, absorption of fat, metabolism of drugs, and conversion of indigestible foods or partially digested food ingredients to molecules that may signal physiological host mechanisms. The gut microbiome is a complex ecosystem of liquor or chime and microbiota. A change in that habitat may result in microbiota community shifts and consequential changes in brain-gut regulatory interactions. NM504 is a cobiotic formulation composed of 3 (generally recognized as safe; GRAS) food ingredients. One ingredient is a conventional prebiotic fiber. A second ingredient can be fermented but it also is included to change the viscosity of the biome while protecting the mucosal barrier. The 3rd ingredient is an antioxidant with poor bioavailability that alters the redox potential of the biome, selecting for some and against other microbiota growth. In a placebo-controlled double-blinded intervention this trial will investigate the effect of NM504 on the intestinal microbiota as well as markers of glucose regulation in 20 prediabetic adults. The intervention periods last 28 days. Examination of participants will happen at the beginning, weekly and at the end of intervention and will contain anthropometry; blood samples; fecal samples; oral glucose tolerance test; meal tolerance test; and scales to assess appetite, hunger, mood, and bowel habits.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the ratio of Bacteroidetes to Firmicuites ratio in the stool comparing the baseline value to the completion of study value.
timeFrame: 4 weeks
Secondary outcomes:
measure: Insulin sensitivity based on homeostasis model assessment (HOMA)
timeFrame: 4 weeks
measure: Fasting blood glucose
timeFrame: Weekly for 4 weeks
measure: Body weight
timeFrame: Weekly for 4 weeks
measure: Hunger perception
timeFrame: Weekly for 4 weeks
measure: Meal tolerance test
timeFrame: 3 weeks
measure: Clinical Chemistry
timeFrame: 4 weeks
measure: Fecal profiling
timeFrame: 4 weeks
measure: Insulin sensitivity based on Oral Glucose Tolerance Testing
timeFrame: 4 weeks
measure: Mood
timeFrame: 4 weeks
measure: Gastrointestinal Symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: