Diet and Hip Fracture Risk in the United Kingdom Women's Cohort

NCT ID: NCT05081466

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35372 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-01-15

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hip fracture is a common serious injury in older women that reduces quality of life and can lead to premature death. In the United Kingdom, hip fractures are estimated to account for 1.5 million hospital bed days used per year due to long hospitalisation and rehabilitation periods post-surgery, costing the National Health Service over £1 billion per year. Diet can affect bone health and risk of hip fracture, with varying risks in women on specific diets, and specific foods and nutrients playing more important roles than others. Vegetarians may be at a greater risk of hip fracture than meat-eaters, and those who don't consume enough protein could be at a greater risk than those with adequate intakes. This research aims to investigate which dietary factors (and in what quantities) might predispose United Kingdom women to a greater risk of hip fracture, and which factors may be protective. The purpose of this study is to better understand the role of diet in reducing hip fracture risk in United Kingdom women. The research will use existing dietary and lifestyle data from the United Kingdom Women's Cohort Study and hospital records of hip fractures.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Hip fracture is an increasingly prevalent global health condition that increases morbidity and mortality. Previous observational studies have shown potential for risk reduction through diet modification, but associations between many dietary factors and hip fracture incidence are uncertain, and evidence in United Kingdom populations is limited. Therefore, this study aims to assess associations between diet and hip fracture incidence in the United Kingdom Women's Cohort.

Research plan and methods: The investigators will utilise dietary and lifestyle data from the United Kingdom Women's Cohort which recruited 35,372 middle-aged women between 1995-1998. This data has been linked with Hospital Episode Statistics to provide hip fracture data of participants.

Cox regression models will be applied to explore potential associations between dietary factors and hip fracture incidence. Dietary factors will be modelled both as categorical and continuous so that models can be fit comparing the risk of hip fracture between categories of intakes and per increment increase in exposure intake (linear dose-response). Cubic splines will be used to model non-linear associations for dietary intake of fruits, vegetables, tea, and coffee since previous research has suggested possible non-linear associations for these variables.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fracture (First Incidence of)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

United Kingdom Women's Cohort

United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study.

Dietary pattern

Intervention Type OTHER

(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)

Fruit and vegetable intake

Intervention Type OTHER

Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire

Meat intake

Intervention Type OTHER

Red meat, poultry, processed meat from food frequency questionnaire

Fish intake

Intervention Type OTHER

Intake of fish from food frequency questionnaire

Egg intake

Intervention Type OTHER

Intake of eggs from food frequency questionnaire

Dairy intake

Intervention Type OTHER

Intake of dairy products from food frequency questionnaire

Tea intake

Intervention Type OTHER

Intake of tea (drink) from food frequency questionnaire

Coffee intake

Intervention Type OTHER

Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire

Tea and coffee intake

Intervention Type OTHER

Combined intake of tea and coffee from food frequency questionnaire

Protein intake

Intervention Type OTHER

Estimated intake of protein, derived from food frequency questionnaire

Calcium intake

Intervention Type OTHER

Estimated intake of calcium, derived from food frequency questionnaire

Vitamin D intake

Intervention Type OTHER

Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary pattern

(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)

Intervention Type OTHER

Fruit and vegetable intake

Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire

Intervention Type OTHER

Meat intake

Red meat, poultry, processed meat from food frequency questionnaire

Intervention Type OTHER

Fish intake

Intake of fish from food frequency questionnaire

Intervention Type OTHER

Egg intake

Intake of eggs from food frequency questionnaire

Intervention Type OTHER

Dairy intake

Intake of dairy products from food frequency questionnaire

Intervention Type OTHER

Tea intake

Intake of tea (drink) from food frequency questionnaire

Intervention Type OTHER

Coffee intake

Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire

Intervention Type OTHER

Tea and coffee intake

Combined intake of tea and coffee from food frequency questionnaire

Intervention Type OTHER

Protein intake

Estimated intake of protein, derived from food frequency questionnaire

Intervention Type OTHER

Calcium intake

Estimated intake of calcium, derived from food frequency questionnaire

Intervention Type OTHER

Vitamin D intake

Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female
* Ages 35 - 69 years at time of recruitment
* Able to provide informed consent

Exclusion Criteria

* Male
* Not a resident of England
* Unable to link dietary and lifestyle data with hospital episode data
* Missing covariate data
* Hip fracture or osteoporosis prevalence before or on the date of recruitment
Minimum Eligible Age

36 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Darren Greenwood

Senior Lecturer in Biostatistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Webster J, Greenwood DC, Cade JE. Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: results from the UK Women's Cohort Study. BMC Med. 2022 Aug 11;20(1):275. doi: 10.1186/s12916-022-02468-0.

Reference Type RESULT
PMID: 35948956 (View on PubMed)

Webster J, Greenwood DC, Cade JE. Foods, nutrients and hip fracture risk: A prospective study of middle-aged women. Clin Nutr. 2022 Dec;41(12):2825-2832. doi: 10.1016/j.clnu.2022.11.008. Epub 2022 Nov 9.

Reference Type DERIVED
PMID: 36402009 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRA 17/YH/0144

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OSTPRE-Fracture Prevention Study
NCT00592917 COMPLETED PHASE4
Prunes Preventing Bone Loss in Perimenopause
NCT07120997 NOT_YET_RECRUITING NA
Effect of Blueberries on Bone Turnover
NCT02630797 UNKNOWN PHASE1/PHASE2
Fall, Fracture and Frailty
NCT05712252 ACTIVE_NOT_RECRUITING