Gut Microbiome, Adiposity, and Probiotics (GMAP)

NCT03533621 | Completed

• 1 other identifier: 141045
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (7)

• Adiposity

  change in total % fat mass as measured by DXA scan measured at baseline (week 0) and study completion (week 12)

  12 weeks

• hsCRP

  high sensitivity C-reactive protein (mg/L) measured at baseline (week 0) and study completion (week 12)

  12 weeks

• IL-6

  Interleukin 6 (pg/ml) measured at baseline (week 0) and study completion (week 12)

  12 weeks

• TNF-alpha

  Tumor necrosis factor alpha (pg/ml) measured at baseline (week 0) and study completion (week 12)

  12 weeks

• Adiponectin

  adiponectin (ug/ml) measured at baseline (week 0) and study completion (week 12)

  12 weeks

• Acceptability of taking pills

  Acceptability of taking pills daily for 12 weeks assessed with 3 separate questions: Did your child take his/her pill daily (1 = not at all, 3 = sometimes, 5 = every day); Did your child have trouble remembering to take his/her pill daily (1 = not at all, easy to remember, 5 = had a lot of trouble remembering); Did your child like taking his/her pill (1 = not at all, 5 = loved it!). Parents were asked to complete these questions at study completion (week 12). The second question will be reverse-scored, and higher scores will indicate better acceptability. Each question will be viewed as separate items, and not combined to create a summary score.

  week 12

• Proportion of participants with side effects

  weekly assessment of any side effects reported by participants including nausea, abdominal pain, bloating, or skin reactions

  12 weeks

Secondary Outcomes (2)

• Bristol Stool chart

  12 weeks

• gut microbiome

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic - VSL#3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo pill - soy protein powder

Interventions

Probiotic - VSL#3 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

Probiotic

Placebo pill - soy protein powder 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

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• BMI \>= 85th percentile
• years old
• parent willing to participate

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Rady Children's Hospital: collaborator

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-control trial. Investigators, subjects, and assessors were unaware of which group they were randomized to. Subjects received pills in a paper bad that looked identical to each other.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Subjects were randomized to probiotic or placebo group, and remained in that group for the 12 week study period.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 23, 2018
• Study Start: September 4, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share