An interventional study of Placebo and NM504: in Pre Diabetic, sponsored by NuMe Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-24.
Sponsored by NuMe Health · Not applicable, Interventional, and Prevention
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.
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's planned enrollment of 45 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →NuMe Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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:
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:
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.
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.
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.
Time frame: 4 weeks
Insulin sensitivity based on homeostasis model assessment (HOMA)
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.
Time frame: 4 weeks
Fasting blood glucose
Weekly measurements of fasting blood glucose and serum insulin will be performed.
Time frame: Weekly for 4 weeks
Body weight
Body weight will be monitored weekly.
Time frame: Weekly for 4 weeks
Hunger perception
Visual analog scales to assess appetite and satiety will be used at weekly visits.
Time frame: Weekly for 4 weeks
Meal tolerance test
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.
Time frame: 3 weeks
Clinical Chemistry
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).
Time frame: 4 weeks
Fecal profiling
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.
Time frame: 4 weeks
Insulin sensitivity based on Oral Glucose Tolerance Testing
An oral glucose tolerance test will be performed at baseline and at the completion of the study to estimate insulin sensitivity.
Time frame: 4 weeks
Mood
A standardized mood instrument will be used at baseline and at 4 weeks.
Time frame: 4 weeks
Gastrointestinal Symptoms
A survey to measure GI symptoms, changes in bowel habits and changes in stool characteristics will be performed on weekly visits for 4 weeks.
Time frame: 4 weeks
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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