NCT05554549

Brief Summary

Hip fracture is a common serious injury in older adults that reduces mobility, independence, and quality of life, and can lead to premature death. Around 1.6 million cases occur globally per year, and continual increases in the number of older adults worldwide suggests that cases could reach 4.5 million by 2050. Diet can affect bone health and risk of hip fracture, with varying risks in adults on specific diets. There is some evidence that vegetarians may have poorer bone health and higher risks of fractures than meat-eaters, but prospective evidence for hip fractures is limited, and the influence of factors including diet quality and body mass index (BMI) are unclear. The main aim of this research is to investigate risk of hip fracture in occasional meat-eaters, pescatarians, and vegetarians compared to regular meat-eaters. A secondary aim is to determine if risk of hip fracture in these diet groups depends on age, sex, diet quality, body mass index, and diet-gene interactions. Thirdly, we will explore the role of potential factors underpinning any risk differences, such as BMI, bone mineral density, and intake of nutrients that are mostly found in animal-sourced foods. The purpose of this study is to better understand hip fracture risk in vegetarian UK adults. The proposed project will use existing diet and lifestyle data from the UK Biobank resource, and hospital records of hip fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2006

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

15.8 years

First QC Date

September 21, 2022

Last Update Submit

November 29, 2023

Conditions

Keywords

NutritionVegetarianFractureCohort studyEpidemiologyOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Hip fracture incidence (first)

    First incidence of hip fracture, identified from all relevant ICD diagnosis codes and treatment codes identified through linked HES data.

    Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2021).

Study Arms (1)

UK Biobank

UK Biobank. There are no interventions in this observational cohort study.

Other: Dietary pattern observed

Interventions

Dietary pattern: regular meat-eater, occasional meat-eater, pescatarian, and vegetarian. There are no interventions in this observational cohort.

UK Biobank

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Information on the UK Biobank cohort profile is available here: https://www.ukbiobank.ac.uk/

You may qualify if:

  • Male or female
  • Ages 40 to 70 years at time of recruitment
  • Able to provide informed consent

You may not qualify if:

  • Unable to link dietary and lifestyle data with hospital episode statistics
  • Had a hip fracture or osteoporosis before or no the date of recruitment
  • Withdrew consent during the study period
  • Genetic sex differs to reported sex
  • Outlier diet or anthropometric data (energy intake \<500 or \>5000 kcal/day or body mass index \<10 or \>60 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (1)

  • Webster J, Greenwood DC, Cade JE. Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: a prospective cohort study of 413,914 UK Biobank participants. BMC Med. 2023 Jul 27;21(1):278. doi: 10.1186/s12916-023-02993-6.

Biospecimen

Retention: SAMPLES WITH DNA

UK Biobank collected biomarker samples with DNA. This project makes use of data from the biomarker samples, but no additional samples will be taken and no additional samples will taken for this research. No samples will be processed, stored or retained by us. For the previously published details of UK Biobank, with anonymised data made available for researchers, please see: https://www.ukbiobank.ac.uk/enable-your-research/about-our-data/biomarker-data

MeSH Terms

Conditions

Hip FracturesFractures, BoneOsteoporosis

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Biostatistics

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

January 1, 2006

Primary Completion

September 30, 2021

Study Completion

July 31, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).

Locations