Gut Microbiome, Adiposity, and Probiotics (GMAP)

NCT ID: NCT03533621

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-04
• Study Completion Date: 2016-12-31

Brief Summary

Recent studies have shown that the bacteria in the gut (gut microbiome) can affect adiposity levels and inflammation. In animal studies, changing these bacteria has been linked with decreased fat mass and inflammation as well as improved metabolism. Probiotics can be a safe method of altering the gut microbiome in humans and have shown promising results in adults with regards to changing adiposity and inflammatory markers. However, it may also be important to provide the right dietary milieu (i.e. high fruit and vegetable/low saturated fat diet) in order to see the benefits of probiotics on these physiologic markers. At this time, no one has offered probiotics in the context of the right dietary milieu and tested it in children. This pilot proposal is innovative because it will be the first to test how well probiotics work in the context of a diet high in fruits and vegetables to change the gut microbiome, decrease fat mass, and improve inflammatory markers in overweight/obese children. This protocol will allow one to better understand the effect of probiotics on these physiologic functions and determine acceptability and feasibility of taking daily probiotics.

Detailed Description

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.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Probiotic

1 Probiotic pill, twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption

Group Type: EXPERIMENTAL

Probiotic - VSL#3

Intervention Type: DIETARY_SUPPLEMENT

Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors

Placebo

1 placebo pill (soy protein powder), twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption

Group Type: PLACEBO_COMPARATOR

Placebo pill - soy protein powder

Intervention Type: DIETARY_SUPPLEMENT

Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors

Interventions

Probiotic - VSL#3

Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors

Intervention Type: DIETARY_SUPPLEMENT

Placebo pill - soy protein powder

Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• BMI >= 85th percentile
• 7-16 years old
• parent willing to participate

Exclusion Criteria

• 1) taking any oral or topical antibiotics or probiotics within the last month prior to the start of the intervention, 2) allergy to milk or milk products, 3) taking any diabetes medication, lipid-lowering drugs, or anti-inflammatory drugs, 4) be immune compromised; 5) 5% weight change or greater within the last three months, 6) psychiatric or medical illness that would hinder their ability to participate in weekly sessions, 7) receiving treatment for a major psychiatric disorder, including an eating disorder, 8) developmental delay such that the intervention materials will not be appropriate, and 9) the possibility of moving out of the area within the time frame of the study.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rady Children's Hospital

UNKNOWN

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kay Rhee

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

141045

Identifier Type: -

Identifier Source: org_study_id