NCT03179657

Brief Summary

Purpose: The Guangzhou Nutrition and Health Study (GNHS) project aims to assess the determinants of metabolic disease in nutritional aspects, as well as other environmental and genetic factors, and explore possible mechanisms with multi-omics integration. Study design: GNHS is a community-based prospective cohort study. Participants: In this cohort, the original GNHS and another cohort study (the controls of a case-control study of hip fractures, CCFH) have been integrated into the one GNHS project. After completing the baseline examination, a total of 5118 participants were recruited during 2008-2015 in the GNHS project. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, dual-energy x-ray absorptiometry (DXA) scanning, ultrasonography evaluation, vascular endothelial function evaluation, cardiopulmonary exercise testing, magnetic resonance imaging (MRI), 14-d real-time continuous glucose monitoring tests, laboratory tests, and multi-omics data were/will be conducted. Up to December 2022, 3442 and 2895 subjects completed the 2nd and 3rd visits. Key variables:

  1. 1.Questionnaire interviews.
  2. 2.Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, muscle function and bracelet motion monitoring.
  3. 3.DXA scanning: To determine bone density, bone mineral content, bone geometry information, fat mass, and muscle mass.
  4. 4.Ultrasonography evaluations: To determine carotid artery intima-media thickness and plaque, and fatty liver.
  5. 5.Vascular endothelial function evaluation.
  6. 6.Cardiopulmonary exercise testing: Lung function.
  7. 7.MRI: Brain and upper-abdomen MRI.
  8. 8.14-d Real-time continuous glucose monitoring tests.
  9. 9.Specimen collections: Overnight fasting blood, early morning first-void urine, faces, and saliva samples.
  10. 10.Laboratory tests: Metabolic syndrome-related indices; Diabetes-related indices; Uric acid; Nutritional indices; Inflammatory cytokines; Index of oxidative stress; Adipocytes; Sexual hormones; Liver and renal function-related markers; Routine blood test.
  11. 11.Multi-omics data: Genotyping data; Gut microbiota; Untargeted serum and fecal proteomics; Targeted serum and fecal metabolomics.
  12. 12.Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,118

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jul 2008

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2008Dec 2027

Study Start

First participant enrolled

July 1, 2008

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

15.4 years

First QC Date

June 1, 2017

Last Update Submit

December 23, 2022

Conditions

Keywords

Prospective Cohort studyNutritionDietMulti-omicsMetabolic diseasesGuangzhouChinese

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular diseases (change in carotid artery intima-media thickness, and occurrence of cardiovascular diseases)

    The investigators will track for occurrence of cardiovascular diseases by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Guangzhou Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews. The investigators will also measure the carotid artery intima-media thickness at each visit (every 3 years),and analyze the change of carotid artery intima-media thickness.

    Up to 15 years

  • Bone health (change of bone mineral density, and occurrence of osteoporosis and fractures)

    The investigators will measure the bone mineral density at each follow-up, and osteoporosis was defined as T-score ≤ -2.5 in accordance with the World Health Organization criteria. The investigators will also track for occurrence of osteoporosis and fractures by follow-up surveys and annual record linkage to the population-based disease or death registration collected by the Guangzhou Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews. Moreover, the investigators will analysis the annual change of bone mineral density.

    Up to 12 years

  • Nonalcoholic fatty liver disease (NAFLD)

    The investigators will measure the abdominal ultrasonography at each follow-up and NAFLD was diagnosed based on standard criteria issued by the Fatty Liver Disease Study Group of the Chinese Liver Disease Association. The upper-abdomen MRI was conducted in the 5th visit and NAFLD was diagnosed based on proton density fat fraction. The investigators will also track for occurrence of NAFLD by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Guangzhou Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.

    Up to 12 years

Secondary Outcomes (8)

  • Change in adiposity-related indices

    Up to 12 years

  • Metabolic syndrome

    Up to 15 years

  • Change in muscle mass

    Up to 12 years

  • Sarcopenia

    Up to 12 years

  • Diabetes mellitus (change of diabetic indices)

    Up to 15 years

  • +3 more secondary outcomes

Eligibility Criteria

Age40 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

4048 participants in the original GNHS (79.1%) and 1070 participants in the CCFH (20.9%) contributed to the GNHS project (5118 participants). The sample of the GNHS project consisted of 68.1% women. At baseline, the median age was 59.0 years. 41.6% and 23.4% of them had education levels of secondary high school and college degree or above. 86.2% were married and 15.8% were smokers. Median BMI was 23.2 kg/m2. Up to December 2022, 5118 participants attended baseline survey, 3442 and 2895 subjects completed the 2nd and 3rd visits. The whole cohort is planned to be followed at least 15 years.

You may qualify if:

  • Age: 40-80 years (the original GNHS) and 40-85 years (CCFH) at baseline;
  • Living in Guangzhou for at least five years;
  • Chinese.

You may not qualify if:

  • Had a history of hospital-confirmed diabetes, failure(s) of heart, liver, or kidney, cancer, cardiovascular events, metabolic bone diseases, glucocorticoid use (over 3 mo.) or sexual hormone use (over 6 mo.), spine or hip fractures;
  • On special diet due to a disease or weight control;
  • Mental and physical disability;
  • Likely to move to other city within 5 years;
  • Did not want to attend any one item of the survey or sample collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Li Z, Huang BX, Huang ZH, Li MC, Chen YM, Zhu HL. Exploring the link between serum betaine levels and hyperuricemia risk in middle-aged and older adults: insights from a prospective cohort study. Eur J Nutr. 2025 Feb 1;64(2):77. doi: 10.1007/s00394-025-03594-0.

  • Xie K, Xiao C, Lin L, Li F, Hu W, Yang Y, Chen D, Miao Z, Sun TY, Yan Y, Zheng JS, Chen YM. Erythrocyte Very Long-Chain Saturated Fatty Acids, Gut Microbiota-Bile Acid Axis, and Incident Coronary Artery Disease in Adults: A Prospective Cohort Study. J Nutr. 2024 Oct;154(10):3019-3030. doi: 10.1016/j.tjnut.2024.08.005. Epub 2024 Aug 10.

  • Chen S, Chen XY, Huang ZH, Fang AP, Li SY, Huang RZ, Chen YM, Huang BX, Zhu HL. Correlation between serum trimethylamine-N-oxide and body fat distribution in middle-aged and older adults: a prospective cohort study. Nutr J. 2024 Jul 9;23(1):70. doi: 10.1186/s12937-024-00974-w.

  • Chen S, Lin X, Ma J, Li M, Chen Y, Fang AP, Zhu HL. Dietary protein intake and changes in muscle mass measurements in community-dwelling middle-aged and older adults: A prospective cohort study. Clin Nutr. 2023 Dec;42(12):2503-2511. doi: 10.1016/j.clnu.2023.10.017. Epub 2023 Oct 22.

  • Wu YY, Gou W, Yan Y, Liu CY, Yang Y, Chen D, Xie K, Jiang Z, Fu Y, Zhu HL, Zheng JS, Chen YM. Gut microbiota and acylcarnitine metabolites connect the beneficial association between equol and adiposity in adults: a prospective cohort study. Am J Clin Nutr. 2022 Dec 19;116(6):1831-1841. doi: 10.1093/ajcn/nqac252.

  • Li SY, Chen S, Lu XT, Fang AP, Chen YM, Huang RZ, Lin XL, Huang ZH, Ma JF, Huang BX, Zhu HL. Serum trimethylamine-N-oxide is associated with incident type 2 diabetes in middle-aged and older adults: a prospective cohort study. J Transl Med. 2022 Aug 18;20(1):374. doi: 10.1186/s12967-022-03581-7.

  • Gu Y, Luo J, Chen Q, Qiu Y, Zhou Y, Wang X, Qian X, Liu Y, Xie J, Xu Z, Ling W, Chen Y, Yang L. Inverse Association of Serum Adipsin with the Remission of Nonalcoholic Fatty-Liver Disease: A 3-Year Community-Based Cohort Study. Ann Nutr Metab. 2022;78(1):21-32. doi: 10.1159/000520368. Epub 2021 Nov 23.

  • Deng YY, Zhong QW, Zhong HL, Xiong F, Ke YB, Chen YM. Higher Healthy Lifestyle Score is associated with lower presence of non-alcoholic fatty liver disease in middle-aged and older Chinese adults: a community-based cross-sectional study. Public Health Nutr. 2021 Oct;24(15):5081-5089. doi: 10.1017/S1368980021000902. Epub 2021 Feb 26.

  • Xiao ML, Lin JS, Li YH, Liu M, Deng YY, Wang CY, Chen YM. Adherence to the Dietary Approaches to Stop Hypertension (DASH) diet is associated with lower presence of non-alcoholic fatty liver disease in middle-aged and elderly adults. Public Health Nutr. 2020 Mar;23(4):674-682. doi: 10.1017/S1368980019002568. Epub 2019 Sep 30.

  • Dong HL, Tang XY, Deng YY, Zhong QW, Wang C, Zhang ZQ, Chen YM. Urinary equol, but not daidzein and genistein, was inversely associated with the risk of type 2 diabetes in Chinese adults. Eur J Nutr. 2020 Mar;59(2):719-728. doi: 10.1007/s00394-019-01939-0. Epub 2019 Apr 5.

  • Chen ZY, Liu M, Jing LP, Xiao ML, Dong HL, Chen GD, Chen YM. Erythrocyte membrane n-3 polyunsaturated fatty acids are inversely associated with the presence and progression of nonalcoholic fatty liver disease in Chinese adults: a prospective study. Eur J Nutr. 2020 Apr;59(3):941-951. doi: 10.1007/s00394-019-01953-2. Epub 2019 Apr 1.

  • Xiao ML, Chen GD, Zeng FF, Qiu R, Shi WQ, Lin JS, Cao Y, Li HB, Ling WH, Chen YM. Higher serum carotenoids associated with improvement of non-alcoholic fatty liver disease in adults: a prospective study. Eur J Nutr. 2019 Mar;58(2):721-730. doi: 10.1007/s00394-018-1678-1. Epub 2018 Mar 29.

Biospecimen

Retention: SAMPLES WITH DNA

12-h fasting venous blood, urine, feces and saliva were/will be collected at baseline and follow-ups.

MeSH Terms

Conditions

Cardiovascular DiseasesOsteoporosisDiabetes Mellitus, Type 2Metabolic SyndromeObesityHypertensionNon-alcoholic Fatty Liver DiseaseRenal Insufficiency, ChronicNeoplasmsDeathNutrition DisordersSarcopeniaMetabolic Diseases

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesFatty LiverLiver DiseasesDigestive System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Officials

  • Yuming Chen

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 7, 2017

Study Start

July 1, 2008

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2027

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share