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

NCT01724736 | Completed

• 1 other identifier: PrCo Study
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetic

Keywords

microbiome; prebiotic; cobiotic; NM504; GI microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Insulin sensitivity based on homeostasis model assessment (HOMA)

  4 weeks

• Fasting blood glucose

  Weekly for 4 weeks

• Body weight

  Weekly for 4 weeks

• Hunger perception

  Weekly for 4 weeks

• Meal tolerance test

  3 weeks

Study Arms (2)

Placebo Comparator:

PLACEBO COMPARATOR

Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.

Drug: Placebo; Drug: NM504:

NM504:

ACTIVE COMPARATOR

Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.

Drug: Placebo; Drug: NM504:

Interventions

Placebo DRUG

Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.

NM504:; Placebo Comparator:

NM504: DRUG

Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.

NM504:; Placebo Comparator:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NuMe Health: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)