Obesity, ChildhoodNCT05671731
Combining Prebiotic and Diet/Physical Activity Educational Program Effects on Body Composition and Intestinal Microbiota in Children
A study testing Beneo Synergy 1 and Project FUN in people with Obesity, Childhood, run by Marquette University.
Trial summary
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Beneo Synergy 1 and Project FUN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2012to 11 Apr 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch.
Who cannot join
- Parents indicated their child had taken an antibiotic in the last month since antibiotics can change intestinal flora though none required exclusion for this reason or for illness preventing participation.
About this study
Official title: The Effect of Combining Prebiotic Treatment With a Diet/Physical Activity Educational Program on Body Composition and Intestinal Microbiota in 4th and 5th Grade Children
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:
H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.
Read more
H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.
Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:
RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention?
Read the detailed description
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:
H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.
H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.
Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:
RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention? The sample included 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch. Of the 123 consenting 56% were male; 71% Latinx; 15% African American; 14% Other. Three percent were underweight; 49% normal weight; 22% overweight; 25% obese.
Consenting Latinx (n=20) and African American (n=8) participants completed microbiome analysis. Of these 54% were male; 6.5% underweight; 38.7% normal weight; 32.3% overweight; 2.6% obese.
- Conditions
- Obesity, Childhood
- Being tested
- Beneo Synergy 1, Project FUN
- Keywords
- prebiotics, Gastrointestinal Microbiome, Hispanic or Latino
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beneo Synergy 1Dietary supplement
Also called oligofructose enhanced inulin
Project FUNBehavioural
Project FUN, a culturally tailored online nutrition and physical activity program is based on the Health Promotion/ Transtheoretical Model. It includes 8 modules offered in a password-protected learning management system along with a workbook also used to assure intervention completion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received Beneo Synergy 1 - 4gm twice/school day in 4 ounces orange juice with calcium for 12 weeks. We started with 1gm then increased the next day by a gram to reach the 4gm dose.
Intervention group participants completed Project FUN (8 module online nutrition and physical activity program) individually (password protected) in the school computer lab along with a workbook also used to check intervention completion. Receives: Dietary Supplement: Beneo Synergy 1; Behavioral: Project FUN |
| Control | No intervention | The control group participated in usual school activities only completing pre and post measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index percentile mean change from baseline after 12 weeks
Weights to the nearest tenth of a pound were collected using a Seca model 8761321004 scale. Heights in stocking feet were measured to the nearest hundredth of an inch with a stadiometer (Seca Model 213, Hanover, MD, USA). Body mass index percentile was calculated using the Centers for Disease Control and Prevention school algorithm including birth date, measurement date, height, and weight
Measured: Pre and after 12-week intervention
Secondary outcomes (2)
Body fat percentage mean change from baseline after 12 weeks
Measured with the Omron HBF-306C hand-held bioimpedance monitor
Measured: Pre and after 12-week intervention
Gut microbiota mean change from baseline after 12 weeks (Intervention group only)
Genomic markers of stool samples were analyzed by Roche 454 pyrosequencing of fecal 16S rDNA and validated by quantitative polymerase chain reaction.
Measured: Pre and after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start13 Nov 2012
- Primary completion11 Apr 2013
- Study completion11 Apr 2013
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled feasibility trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671731
- Sponsor's protocol ID
- 2411
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no data repository for sharing of individual data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Prebiotic Treatment With a Diet/Physical Activity Educational Program on Body Composition and Intestinal Microbiota in 4th and 5th Grade Children
- ClinicalTrials.gov ID
- NCT05671731
- Acronym / sponsor ID
- 2411
- Conditions
- Obesity, Childhood
- Keywords
- prebiotics, Gastrointestinal Microbiome, Hispanic or Latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- 13 Nov 2012 (actual)
- Primary completion
- 11 Apr 2013 (actual)
- Study completion
- 11 Apr 2013 (actual)
- First posted
- 5 Jan 2023 (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.
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:
H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.
H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.
Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:
RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention?
Detailed description
The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:
H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.
H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.
Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:
RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention? The sample included 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch. Of the 123 consenting 56% were male; 71% Latinx; 15% African American; 14% Other. Three percent were underweight; 49% normal weight; 22% overweight; 25% obese.
Consenting Latinx (n=20) and African American (n=8) participants completed microbiome analysis. Of these 54% were male; 6.5% underweight; 38.7% normal weight; 32.3% overweight; 2.6% obese.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cluster randomized controlled feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Beneo Synergy 1, Behavioral: Project FUNThe intervention group received Beneo Synergy 1 - 4gm twice/school day in 4 ounces orange juice with calcium for 12 weeks. We started with 1gm then increased the next day by a gram to reach the 4gm dose. Intervention group participants completed Project FUN (8 module online nutrition and physical activity program) individually (password protected) in the school computer lab along with a workbook also used to check intervention completion. |
| Control | No intervention | –The control group participated in usual school activities only completing pre and post measures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch.
Key exclusion criteria (1 listed)
- Parents indicated their child had taken an antibiotic in the last month since antibiotics can change intestinal flora though none required exclusion for this reason or for illness preventing participation.
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 |
|---|---|---|
| Beneo Synergy 1Also: oligofructose enhanced inulin | Dietary supplement | Intervention |
| Project FUNProject FUN, a culturally tailored online nutrition and physical activity program is based on the Health Promotion/ Transtheoretical Model. It includes 8 modules offered in a password-protected learning management system along with a workbook also used to assure intervention completion. | Behavioural | Intervention |
Primary outcome
Body mass index percentile mean change from baseline after 12 weeks
Time frame: Pre and after 12-week intervention
Weights to the nearest tenth of a pound were collected using a Seca model 8761321004 scale. Heights in stocking feet were measured to the nearest hundredth of an inch with a stadiometer (Seca Model 213, Hanover, MD, USA). Body mass index percentile was calculated using the Centers for Disease Control and Prevention school algorithm including birth date, measurement date, height, and weight
2 secondary outcomes
Body fat percentage mean change from baseline after 12 weeks
Time frame: Pre and after 12-week intervention
Gut microbiota mean change from baseline after 12 weeks (Intervention group only)
Time frame: Pre and after 12-week intervention
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 5 Jan 2023.
- Individual participant dataSharing planned: No. At this time there is no data repository for sharing of individual data.
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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 Beneo Synergy 1 and Project FUN in people with Obesity, Childhood, run by Marquette University.
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 1 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 5 Jan 2023. 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. 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?
Body mass index percentile mean change from baseline after 12 weeks (time frame: Pre and after 12-week intervention). 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 5 Jan 2023.