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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuMe Health
ClinicalTrials.gov Identifier:
NCT01724736
First received: November 6, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pre Diabetic
Drug: Placebo
Drug: NM504:

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Determine the Effect of a Cobiotic Formulation on the Fecal Bacteroidetes: Firmicutes Ratio in Pre-Diabetic Subjects.

Resource links provided by NLM:


Further study details as provided by NuMe Health:

Primary Outcome Measures:
  • Change in the ratio of Bacteroidetes to Firmicuites ratio in the stool comparing the baseline value to the completion of study value. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Insulin sensitivity based on homeostasis model assessment (HOMA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Fasting blood glucose [ Time Frame: Weekly for 4 weeks ] [ Designated as safety issue: No ]
    Weekly measurements of fasting blood glucose and serum insulin will be performed.

  • Body weight [ Time Frame: Weekly for 4 weeks ] [ Designated as safety issue: No ]
    Body weight will be monitored weekly.

  • Hunger perception [ Time Frame: Weekly for 4 weeks ] [ Designated as safety issue: No ]
    Visual analog scales to assess appetite and satiety will be used at weekly visits.

  • Meal tolerance test [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Clinical Chemistry [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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).

  • Fecal profiling [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Insulin sensitivity based on Oral Glucose Tolerance Testing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    An oral glucose tolerance test will be performed at baseline and at the completion of the study to estimate insulin sensitivity.

  • Mood [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    A standardized mood instrument will be used at baseline and at 4 weeks.

  • Gastrointestinal Symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    A survey to measure GI symptoms, changes in bowel habits and changes in stool characteristics will be performed on weekly visits for 4 weeks.


Estimated Enrollment: 45
Study Start Date: November 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: NM504:
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.
Active Comparator: NM504:
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
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: NM504:
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724736

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
NuMe Health
  More Information

No publications provided

Responsible Party: NuMe Health
ClinicalTrials.gov Identifier: NCT01724736     History of Changes
Other Study ID Numbers: PrCo Study
Study First Received: November 6, 2012
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuMe Health:
microbiome
prebiotic
cobiotic
NM504
GI microbiome

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014