Bone DensityNCT07256314
Linking Dietary Nutrition, Dietary Patterns, Gut Microbiota, and Bone Density: A Cross-Sectional Study
An observational study of Bone Density and Gut Microbiomes, run by Jianhua Ma at 1 site in China.
Trial summary
The study aims to understand the current situation of bone health in the Gannan Tibetan primary school student population, to explore the relationship between nutrition, intestinal microorganisms and bone health, to analyze the main factors affecting bone health from the perspective of nutrition and intestinal… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Gut Microbiomes
- How many people
- 431 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 31 Mar 2025
- Phase
- Observational
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study is based on a cross-sectional design. Two schools were selected: one rural primary school in Xiahe County, Gannan Tibetan Autonomous Prefecture, and one urban primary school in Hezuo City, Gansu Province. Within the selected schools, a stratified random cluster sampling method was used to randomly select one class from each grade as the study subjects.
Who may be able to join
- Tibetan primary school students currently enrolled in schools in Gannan Tibetan Autonomous Prefecture;
- Willing to participate and able to cooperate in completing bone density measurements;
- Additional inclusion criteria: Subjects who are 9 years old or older and agree to participate in dietary surveys and fecal sampling.
- Exclusion Criteria:Use of corticosteroid medications within the past year;
- Suffering from skeletal system diseases, metabolic disorders, or endocrine diseases;
- Additional exclusion criteria: Subjects who have used antibiotics in the past three months and are undergoing fecal sampling.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Diet and Gut Microecology on Bone Health in Gannan Tibetan Elementary School Students
The study aims to understand the current situation of bone health in the Gannan Tibetan primary school student population, to explore the relationship between nutrition, intestinal microorganisms and bone health, to analyze the main factors affecting bone health from the perspective of nutrition and intestinal microecology, and to provide theoretical basis for the promotion and improvement of bone health in Tibetan primary school students.
- Conditions
- Bone Density, Gut Microbiomes
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Good Bone Density group and normal bone density group | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Characteristics
Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.
Measured: Day 1
Bone density test
In this study, a peripheral dual-energy X-ray absorptiometry (EXA-PRESTO) was used to measure the bone density of the non-dominant forearm of the subjects.
Measured: Day1
Fecal sample microbiological testing and analysis
This study entrusted Tianhao Gene Technology Co., Ltd. to perform the intestinal microbiome Accu16STM (16S rRNA absolute quantitative sequencing). The main research processes include DNA extraction, PCR amplification, library construction, and sequencing.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start10 Oct 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianhua Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianhua Ma, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256314
- Sponsor's protocol ID
- IRB23082901
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 5 Dec 2025
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Diet and Gut Microecology on Bone Health in Gannan Tibetan Elementary School Students
- ClinicalTrials.gov ID
- NCT07256314
- Acronym / sponsor ID
- IRB23082901
- Conditions
- Bone Density, Gut Microbiomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Jianhua MaUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 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.
The study aims to understand the current situation of bone health in the Gannan Tibetan primary school student population, to explore the relationship between nutrition, intestinal microorganisms and bone health, to analyze the main factors affecting bone health from the perspective of nutrition and intestinal microecology, and to provide theoretical basis for the promotion and improvement of bone health in Tibetan primary school students.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Good Bone Density group and normal bone density group | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study is based on a cross-sectional design. Two schools were selected: one rural primary school in Xiahe County, Gannan Tibetan Autonomous Prefecture, and one urban primary school in Hezuo City, Gansu Province. Within the selected schools, a stratified random cluster sampling method was used to randomly select one class from each grade as the study subjects.
Key inclusion criteria (7 listed)
- Tibetan primary school students currently enrolled in schools in Gannan Tibetan Autonomous Prefecture;
- Willing to participate and able to cooperate in completing bone density measurements;
- Additional inclusion criteria: Subjects who are 9 years old or older and agree to participate in dietary surveys and fecal sampling.
- Exclusion Criteria:Use of corticosteroid medications within the past year;
- Suffering from skeletal system diseases, metabolic disorders, or endocrine diseases;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention | Other | Good Bone Density group and normal bone density group |
Primary outcome
Dietary Characteristics
Time frame: Day 1
Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.
Bone density test
Time frame: Day1
In this study, a peripheral dual-energy X-ray absorptiometry (EXA-PRESTO) was used to measure the bone density of the non-dominant forearm of the subjects.
Fecal sample microbiological testing and analysis
Time frame: Day 1
This study entrusted Tianhao Gene Technology Co., Ltd. to perform the intestinal microbiome Accu16STM (16S rRNA absolute quantitative sequencing). The main research processes include DNA extraction, PCR amplification, library construction, and sequencing.
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 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Density and Gut Microbiomes, run by Jianhua Ma 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 0 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 Dec 2025. 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?
Dietary Characteristics (time frame: Day 1). The study lists 3 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 5 Dec 2025.