- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256314
Linking Dietary Nutrition, Dietary Patterns, Gut Microbiota, and Bone Density: A Cross-Sectional Study
Investigating the Effects of Diet and Gut Microecology on Bone Health in Gannan Tibetan Elementary School Students
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gansu
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Lanzhou, Gansu, China, 730000
- LanZhou University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Good Bone Density group and normal bone density group
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No Intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dietary Characteristics
Time Frame: Day 1
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Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.
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Day 1
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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.
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Day1
|
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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.
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Day 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB23082901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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