Linking Dietary Nutrition, Dietary Patterns, Gut Microbio... | NCT07256314

Studies
Linking Dietary Nutrition, Dietary Patterns, Gut Microbiota, and Bone Density: A Cross-Sectional Study

NCT07256314

Sponsor

Jianhua Ma

Status

Completed

Last Update Posted

Dec 5, 2025Actual

Enrollment

431Actual

Phase

Not provided

Conditions

Bone Density
Gut Microbiomes

Interventions

No Intervention: Observational Cohort

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2023Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Mar 31, 2025Actual

First Submitted Date

Nov 20, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Dec 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 microecology, and to provide theoretical basis for the promotion and improvement of bone health in Tibetan primary school students.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

431Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Good Bone Density group and normal bone density group			Other: No Intervention: Observational Cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	No Intervention	Good Bone Density group and normal bone density group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dietary Characteristics	Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.	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.	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.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

13 Years

Standard Ages

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Lanzhou university		Lanzhou	Gansu	730000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided