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

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.

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.