Obesity, ChildhoodGMAPNCT03533621
Gut Microbiome, Adiposity, and Probiotics (GMAP)
A study testing Probiotic - VSL#3 in people with Obesity, Childhood, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Probiotic - VSL#3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI >= 85th percentile
- 7-16 years old
- parent willing to participate
Who cannot join
- 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.
About this study
Official title: The Effect of Probiotics on Gut Microbiome and Adiposity
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.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- Probiotic - VSL#3, Placebo pill - soy protein powder
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - VSL#3Dietary 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 pill - soy protein powderDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 1 Probiotic pill, twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption Receives: 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 Receives: Dietary Supplement: Placebo pill - soy protein powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiposity
change in total % fat mass as measured by DXA scan measured at baseline (week 0) and study completion (week 12)
Measured: 12 weeks
hsCRP
high sensitivity C-reactive protein (mg/L) measured at baseline (week 0) and study completion (week 12)
Measured: 12 weeks
IL-6
Interleukin 6 (pg/ml) measured at baseline (week 0) and study completion (week 12)
Measured: 12 weeks
TNF-alpha
Tumor necrosis factor alpha (pg/ml) measured at baseline (week 0) and study completion (week 12)
Measured: 12 weeks
Adiponectin
adiponectin (ug/ml) measured at baseline (week 0) and study completion (week 12)
Measured: 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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (2)
Bristol Stool chart
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)
Measured: 12 weeks
gut microbiome
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start4 Sep 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomized to probiotic or placebo group, and remained in that group for the 12 week study period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital San Diego Academic Enrichment Fund
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533621
- Sponsor's protocol ID
- 141045
- Acronym
- GMAP
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Gut Microbiome and Adiposity
- ClinicalTrials.gov ID
- NCT03533621
- Acronym / sponsor ID
- GMAP / 141045
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Rady Children's Hospital San Diego Academic Enrichment Fund
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects were randomized to probiotic or placebo group, and remained in that group for the 12 week study period.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic - VSL#31 Probiotic pill, twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption |
| Placebo | Placebo comparator | Dietary Supplement: Placebo pill - soy protein powder1 placebo pill (soy protein powder), twice a day, for 12 weeks + 20 min weekly support to increase fruit and vegetable consumption |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI >= 85th percentile
- 7-16 years old
- parent willing to participate
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic - VSL#3Subjects 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 | Dietary supplement | Probiotic |
| Placebo pill - soy protein powderSubjects 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 | Dietary supplement | Placebo |
Primary outcome
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)
hsCRP
Time frame: 12 weeks
high sensitivity C-reactive protein (mg/L) measured at baseline (week 0) and study completion (week 12)
IL-6
Time frame: 12 weeks
Interleukin 6 (pg/ml) measured at baseline (week 0) and study completion (week 12)
TNF-alpha
Time frame: 12 weeks
Tumor necrosis factor alpha (pg/ml) measured at baseline (week 0) and study completion (week 12)
Adiponectin
Time frame: 12 weeks
adiponectin (ug/ml) measured at baseline (week 0) and study completion (week 12)
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.
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
2 secondary outcomes
Bristol Stool chart
Time frame: 12 weeks
gut microbiome
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic - VSL#3 in people with Obesity, Childhood, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adiposity (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.