Gut Microbiome, Adiposity, and Probiotics (GMAP)

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2014
The goal is to study the effect of probiotics on changing the gut microbiome of overweight/obese children. Since there appears to be a diet‐by‐microbiota interaction for optimal effects on adiposity, it will be important to administer the probiotics within the context of increased fruit/vegetable (F/V) intake and decreased fat intake. Because changes in diet alone can also induce changes in the gut microbiota, this study will use a double‐blind, randomized, placebo‐control design to determine whether changes in gut microbiota are greater with the addition of probiotics (High F/V diet + Probiotics) compared to diet alone (High F/V diet + Placebo). The primary aim is to test the effect of these 2 arms on changing the gut microbiota, fat mass, and inflammation in children. The study will also examine the acceptability of taking probiotics and changes in other physiologic measures. The Specific aims of this proposal are: 1. To examine the effect of diet high in F/V +/‐ probiotics on change in gut microbiota, adiposity, and inflammation (measured by C‐reactive protein, TNF‐a, and IL‐6); 2. To examine the effect of diet high in F/V +/‐ probiotics on physiologic measures including blood pressure, fasting insulin and glucose, and adiponectin; 3. To determine the acceptability and feasibility of taking daily probiotics over a 12 week period.
Epistemonikos ID: 77eacf0d87dc443a784fd5d38ec0b7dbc132d84b
First added on: May 21, 2024