HealthyPA-MicrobiomeNCT07310654
Physical Activity and Gut Microbiota in Children (PA-Microbiome Kids)
A study testing 16-week Structured MVPA Program in people with Healthy, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
Trial summary
This study evaluates the effect of a 16-week moderate-to-vigorous physical activity (MVPA) program on physical fitness and gut microbiota in healthy school-aged children. Participants will be randomly assigned to either an MVPA intervention group or an attention-control group. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 16-week Structured MVPA Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 May 2026
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants from a previous cross-sectional study cohort conducted in 2023 (Pan et al., Sci Rep 2025;15:21351), at which time they were 6-9 years old.
- Able to complete the 16-week follow-up.
- Guardian provides written informed consent, and the child provides assent.
- Medically cleared by a physician or school nurse to participate in moderate-intensity physical activity (no contraindications).
- No antibiotic use in the 4 weeks prior to baseline.
- No fever or acute gastroenteritis in the 2 weeks prior to baseline.
- Able to provide stool samples as required.
Who cannot join
- Diagnosed with cardiopulmonary diseases, epilepsy, severe asthma, severe musculoskeletal disorders, or congenital heart disease.
- Recent acute exacerbation of chronic gastrointestinal diseases.
- Planning to follow a special diet (e.g., ketogenic, vegetarian) or requiring long-term prescription of antibiotics/probiotics.
- Planning to be absent for >20% of the intervention period due to travel or other commitments.
- Enrolled in other high-intensity sports training programs that cannot be cancelled.
- Developmental or behavioral issues that would impede cooperation, as assessed by teachers and parents.
Trial locations and contacts
1 site in 1 country.
China1 site
Aiyoudong Children and Youth Sports Health Research Institute
Weifang, Shandong, 261000
About this study
Official title: Effects of a 16-week Moderate-to-Vigorous Physical Activity Program on Physical Fitness and Gut Microbiota in Children: A Randomized Controlled Trial
This study evaluates the effect of a 16-week moderate-to-vigorous physical activity (MVPA) program on physical fitness and gut microbiota in healthy school-aged children. Participants will be randomly assigned to either an MVPA intervention group or an attention-control group. The primary outcome is the change in a composite physical fitness score. Secondary outcomes include changes in gut microbiota diversity and composition.
Read the detailed description
This is a two-arm, parallel-group, randomized controlled trial with 1:1 allocation, conducted as an intervention extension of a previously published cross-sectional cohort study (Pan et al., Sci Rep 2025;15:21351; GSA-Human HRA010530). Healthy children aged 7-11 years at the time of intervention baseline (December 2025), who were 6-9 years old when they participated in the 2023 cross-sectional study in Weifang, Shandong, will be included.
In the 2023 baseline study, 120 children were sampled across four PA×PF quadrant groups defined by quartiles of physical activity (PA) and physical fitness (PF): P1 (low PA-low PF), P2 (high PA-low PF), P3 (low PA-high PF), and P4 (high PA-high PF). Of these, 113 provided valid baseline fecal samples and physical fitness data. These 113 participants were re-contacted and re-randomized 1:1 to MVPA or attention-control arms in December 2025. Randomization is stratified by baseline PA×PF quadrant (P1-P4) to ensure balanced allocation of baseline gut microbiome phenotypes across intervention and control arms. The reported enrollment of 113 refers to the number re-randomized at the intervention baseline (T1), not new recruits.
The intervention group will receive a 16-week structured MVPA program (3 sessions/week, 45-60 min/session). The control group will receive attention-matched sedentary activities (e.g., reading, crafts) and will be offered the MVPA program after the trial (waitlist). This is a PROBE-design trial: participants and intervention instructors are not blinded to group assignment, while outcome assessors (physical fitness tests) and laboratory/bioinformatics personnel (microbiota analysis) are blinded to allocation. The database uses codes (e.g., Group A/B) until primary analysis is complete. The primary analysis will follow the intention-to-treat (ITT) principle.
The study aims to (1) determine whether the MVPA intervention improves physical fitness and modulates the gut microbiota, and (2) determine whether baseline PA×PF quadrant membership and baseline abundance of key microbial taxa (Akkermansia, Faecalibacterium, Subdoligranulum, Bacteroides coprocola) modify the intervention response, thereby informing precision exercise prescription strategies.
Ethics and Oversight: This study operates under a collaborative framework in which the China Institute of Sport Science (CISS) serves as the primary institution responsible for ethical oversight and scientific integrity, while Aiyoudong Children and Youth Sports Health Research Institute serves as the implementing institution. Ethical approval was granted by the Ethics Committee of CISS (approval number: CISSLA20230110), covering both the 2023 baseline cross-sectional study and the current intervention extension. Aiyoudong Institute, which does not maintain an independent ethics committee, conducts the intervention under CISS oversight through a formal inter-institutional data use and oversight agreement. Written informed consent was obtained from legal guardians and assent from child participants at both baseline (2023) and intervention enrollment (December 2025).
Exploratory aim: to characterise the co-variation between intervention-induced changes in physical activity, physical fitness, gut microbiota, and psychosocial and behavioural measures, with the gut microbiota as the central node. These analyses are exploratory and hypothesis-generating, and no specific direction of change in the psychosocial or behavioural measures is presumed.
- Conditions
- Healthy
- Being tested
- 16-week Structured MVPA Program, Attention Control Sedentary Activities
- Keywords
- Physical Activity, Gut Microbiota, Microbiome, Physical Fitness, Children, Health Promotion
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week Structured MVPA ProgramBehavioural
A 16-week structured moderate-to-vigorous physical activity program.
Attention Control Sedentary ActivitiesBehavioural
Time-matched sedentary activities such as reading, science experiments, or crafts.
| Study group | Role | What they receive |
|---|---|---|
| MVPA Program | Experimental | Participants will engage in a 16-week structured moderate-to-vigorous physical activity (MVPA) program, 3 times per week, for 45-60 minutes per session. Sessions include warm-up, aerobic games, bodyweight strength circuits, and cool-down, supervised by trained instructors. Receives: Behavioral: 16-week Structured MVPA Program |
| Attention Control + Waitlist | Other | Participants engage in time-matched sedentary activities such as reading, science experiments, or crafts, three times per week, and are instructed to maintain their usual physical activity levels. After the 16-week trial period, they are offered a comparable MVPA program (waitlist). Receives: Behavioral: Attention Control Sedentary Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Physical Fitness Z-score
Change from Baseline to 16 weeks in a composite physical fitness z-score. The score is calculated based on the age-appropriate items and weighting from the "National Student Physical Health Standard (2014 Revision)". The scale is a standardized z-score with a mean of 0 and a standard deviation of 1, based on a reference population. There are no theoretical upper or lower limits, but values typically range from -3 to +3. A higher score indicates better overall physical fitness.
Measured: Baseline and 16 weeks
Secondary outcomes (5)
Change in Gut Microbiota Alpha Diversity
Change from Baseline to 16 weeks in alpha diversity indices (Shannon and Chao1) of the gut microbiota, assessed via 16S rRNA gene sequencing. The Shannon index has a minimum value of 0, with no theoretical maximum. The Chao1 index estimates species richness with a minimum equal to the number of observed species, and also has no theoretical maximum. For both indices, higher values indicate greater diversity and are generally considered to reflect a healthier gut microbiome.
Measured: Baseline and 16 weeks
Difference in Gut Microbiota Beta Diversity
Difference in gut microbiota community structure (beta diversity) between the MVPA and control groups. This will be assessed using a Permutational Multivariate Analysis of Variance (PERMANOVA) on Bray-Curtis and UniFrac distance matrices. The outcome will be reported as an R-squared value, representing the percentage of variance in community structure explained by group assignment, and a p-value. A larger R-squared value and a smaller p-value would indicate a more significant difference between the groups.
Measured: Baseline and 16 weeks
Change in Body Mass Index (BMI) Z-score
Change from Baseline to 16 weeks in age- and sex-specific BMI z-score. This is a standardized score with a mean of 0, based on a reference population, and has no theoretical upper or lower limits. A higher score indicates a higher BMI relative to peers. In the context of this study focusing on healthy weight, an increase in the z-score is generally considered a worse outcome.
Measured: Baseline and 16 weeks
Heterogeneity of Treatment Effect Across Baseline PA×PF Quadrants
Heterogeneity of treatment effect (HTE) of the MVPA intervention on primary and secondary outcomes across the four pre-specified baseline phenotype groups (P1: low PA-low PF; P2: high PA-low PF; P3: low PA-high PF; P4: high PA-high PF) defined in the 2023 cross-sectional study. HTE will be assessed by including a Treatment × Baseline Quadrant interaction term in mixed-effects models. A statistically significant interaction (p < 0.05) would indicate that the intervention effect differs across baseline microbiome phenotypes. Effect sizes will be reported separately for each quadrant with 95% confidence intervals.
Measured: Baseline and 16 weeks
Baseline Microbial Taxa as Effect Modifiers of Intervention Response
Pre-specified analysis of whether baseline relative abundance (continuous, log-transformed) of Akkermansia, Faecalibacterium, Subdoligranulum, and Bacteroides coprocola modifies the MVPA intervention effect on composite physical fitness z-score and alpha diversity. Interaction terms (Treatment × Baseline Taxon Abundance) will be tested in mixed-effects models.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start31 Dec 2025
- Primary completion22 Apr 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiang, Aiyoudong Children and Youth Sports Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310654
- Sponsor's protocol ID
- PA-Microbiome-Kids-2025
- Other IDs
- 2244
- Acronym
- PA-Microbiome
- Status last verified
- May 2026
- First submitted
- 3 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data including 16S rRNA sequencing reads, alpha/beta diversity indices, taxonomic relative abundance tables, physical fitness test results, and physical activity assessment scores will be shared. Sequencing reads from the 2023 baseline have been deposited in the Genome Sequence Archive (GSA-Human: HRA010530). Intervention-phase sequencing data will be deposited in the same repository upon publication of the primary results manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 16-week Moderate-to-Vigorous Physical Activity Program on Physical Fitness and Gut Microbiota in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07310654
- Acronym / sponsor ID
- PA-Microbiome / PA-Microbiome-Kids-2025
- Conditions
- Healthy
- Keywords
- Physical Activity, Gut Microbiota, Microbiome, Physical Fitness, Children, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research InstituteUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 30 Dec 2025 (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.
This study evaluates the effect of a 16-week moderate-to-vigorous physical activity (MVPA) program on physical fitness and gut microbiota in healthy school-aged children. Participants will be randomly assigned to either an MVPA intervention group or an attention-control group. The primary outcome is the change in a composite physical fitness score. Secondary outcomes include changes in gut microbiota diversity and composition.
Detailed description
This is a two-arm, parallel-group, randomized controlled trial with 1:1 allocation, conducted as an intervention extension of a previously published cross-sectional cohort study (Pan et al., Sci Rep 2025;15:21351; GSA-Human HRA010530). Healthy children aged 7-11 years at the time of intervention baseline (December 2025), who were 6-9 years old when they participated in the 2023 cross-sectional study in Weifang, Shandong, will be included.
In the 2023 baseline study, 120 children were sampled across four PA×PF quadrant groups defined by quartiles of physical activity (PA) and physical fitness (PF): P1 (low PA-low PF), P2 (high PA-low PF), P3 (low PA-high PF), and P4 (high PA-high PF). Of these, 113 provided valid baseline fecal samples and physical fitness data. These 113 participants were re-contacted and re-randomized 1:1 to MVPA or attention-control arms in December 2025. Randomization is stratified by baseline PA×PF quadrant (P1-P4) to ensure balanced allocation of baseline gut microbiome phenotypes across intervention and control arms. The reported enrollment of 113 refers to the number re-randomized at the intervention baseline (T1), not new recruits.
The intervention group will receive a 16-week structured MVPA program (3 sessions/week, 45-60 min/session). The control group will receive attention-matched sedentary activities (e.g., reading, crafts) and will be offered the MVPA program after the trial (waitlist). This is a PROBE-design trial: participants and intervention instructors are not blinded to group assignment, while outcome assessors (physical fitness tests) and laboratory/bioinformatics personnel (microbiota analysis) are blinded to allocation. The database uses codes (e.g., Group A/B) until primary analysis is complete. The primary analysis will follow the intention-to-treat (ITT) principle.
The study aims to (1) determine whether the MVPA intervention improves physical fitness and modulates the gut microbiota, and (2) determine whether baseline PA×PF quadrant membership and baseline abundance of key microbial taxa (Akkermansia, Faecalibacterium, Subdoligranulum, Bacteroides coprocola) modify the intervention response, thereby informing precision exercise prescription strategies.
Ethics and Oversight: This study operates under a collaborative framework in which the China Institute of Sport Science (CISS) serves as the primary institution responsible for ethical oversight and scientific integrity, while Aiyoudong Children and Youth Sports Health Research Institute serves as the implementing institution. Ethical approval was granted by the Ethics Committee of CISS (approval number: CISSLA20230110), covering both the 2023 baseline cross-sectional study and the current intervention extension. Aiyoudong Institute, which does not maintain an independent ethics committee, conducts the intervention under CISS oversight through a formal inter-institutional data use and oversight agreement. Written informed consent was obtained from legal guardians and assent from child participants at both baseline (2023) and intervention enrollment (December 2025).
Exploratory aim: to characterise the co-variation between intervention-induced changes in physical activity, physical fitness, gut microbiota, and psychosocial and behavioural measures, with the gut microbiota as the central node. These analyses are exploratory and hypothesis-generating, and no specific direction of change in the psychosocial or behavioural measures is presumed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVPA Program | Experimental | Behavioral: 16-week Structured MVPA ProgramParticipants will engage in a 16-week structured moderate-to-vigorous physical activity (MVPA) program, 3 times per week, for 45-60 minutes per session. Sessions include warm-up, aerobic games, bodyweight strength circuits, and cool-down, supervised by trained instructors. |
| Attention Control + Waitlist | Other | Behavioral: Attention Control Sedentary ActivitiesParticipants engage in time-matched sedentary activities such as reading, science experiments, or crafts, three times per week, and are instructed to maintain their usual physical activity levels. After the 16-week trial period, they are offered a comparable MVPA program (waitlist). |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants from a previous cross-sectional study cohort conducted in 2023 (Pan et al., Sci Rep 2025;15:21351), at which time they were 6-9 years old.
- Able to complete the 16-week follow-up.
- Guardian provides written informed consent, and the child provides assent.
- Medically cleared by a physician or school nurse to participate in moderate-intensity physical activity (no contraindications).
- No antibiotic use in the 4 weeks prior to baseline.
Key exclusion criteria (6 listed)
- Diagnosed with cardiopulmonary diseases, epilepsy, severe asthma, severe musculoskeletal disorders, or congenital heart disease.
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 |
|---|---|---|
| 16-week Structured MVPA ProgramA 16-week structured moderate-to-vigorous physical activity program. | Behavioural | MVPA Program |
| Attention Control Sedentary ActivitiesTime-matched sedentary activities such as reading, science experiments, or crafts. | Behavioural | Attention Control + Waitlist |
Primary outcome
Change in Composite Physical Fitness Z-score
Time frame: Baseline and 16 weeks
Change from Baseline to 16 weeks in a composite physical fitness z-score. The score is calculated based on the age-appropriate items and weighting from the "National Student Physical Health Standard (2014 Revision)". The scale is a standardized z-score with a mean of 0 and a standard deviation of 1, based on a reference population. There are no theoretical upper or lower limits, but values typically range from -3 to +3. A higher score indicates better overall physical fitness.
5 secondary outcomes
Change in Gut Microbiota Alpha Diversity
Time frame: Baseline and 16 weeks
Difference in Gut Microbiota Beta Diversity
Time frame: Baseline and 16 weeks
Change in Body Mass Index (BMI) Z-score
Time frame: Baseline and 16 weeks
Heterogeneity of Treatment Effect Across Baseline PA×PF Quadrants
Time frame: Baseline and 16 weeks
Baseline Microbial Taxa as Effect Modifiers of Intervention Response
Time frame: Baseline and 16 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 3 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data including 16S rRNA sequencing reads, alpha/beta diversity indices, taxonomic relative abundance tables, physical fitness test results, and physical activity assessment scores will be shared. Sequencing reads from the 2023 baseline have been deposited in the Genome Sequence Archive (GSA-Human: HRA010530). Intervention-phase sequencing data will be deposited in the same repository upon publication of the primary results manuscript.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-week Structured MVPA Program in people with Healthy, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
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 7 inclusion and 6 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Composite Physical Fitness Z-score (time frame: Baseline and 16 weeks). 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 3 Jun 2026.