- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03533621
Gut Microbiome, Adiposity, and Probiotics (GMAP) (GMAP)
The Effect of Probiotics on Gut Microbiome and Adiposity
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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);
- To examine the effect of diet high in F/V +/- probiotics on physiologic measures including blood pressure, fasting insulin and glucose, and adiponectin;
- To determine the acceptability and feasibility of taking daily probiotics over a 12 week period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Probiotic
1 Probiotic pill, twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption
|
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_COMPARATOR: Placebo
1 placebo pill (soy protein powder), twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adiposity
Time Frame: 12 weeks
|
change in total % fat mass as measured by DXA scan measured at baseline (week 0) and study completion (week 12)
|
12 weeks
|
hsCRP
Time Frame: 12 weeks
|
high sensitivity C-reactive protein (mg/L) measured at baseline (week 0) and study completion (week 12)
|
12 weeks
|
IL-6
Time Frame: 12 weeks
|
Interleukin 6 (pg/ml) measured at baseline (week 0) and study completion (week 12)
|
12 weeks
|
TNF-alpha
Time Frame: 12 weeks
|
Tumor necrosis factor alpha (pg/ml) measured at baseline (week 0) and study completion (week 12)
|
12 weeks
|
Adiponectin
Time Frame: 12 weeks
|
adiponectin (ug/ml) measured at baseline (week 0) and study completion (week 12)
|
12 weeks
|
Acceptability of taking pills
Time Frame: week 12
|
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
Time Frame: 12 weeks
|
weekly assessment of any side effects reported by participants including nausea, abdominal pain, bloating, or skin reactions
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bristol Stool chart
Time Frame: 12 weeks
|
changes in stooling pattern as assessed by the Bristol Stool Chart, measured at baseline (week 0), weekly during the study (weeks 1-11), and study completion (week 12)
|
12 weeks
|
gut microbiome
Time Frame: 12 weeks
|
Changes in the composition and alpha and beta diversity of the gut microbiome using 16SrRNA amplicon sequencing.
DNA sequencing will be performed using MiSeq platforms.
Samples were obtained at baseline (week 0) and study completion (week 12).
|
12 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 141045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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