Hip FracturesNCT05554549
Dietary Patterns and Hip Fracture Risk in the UK Biobank
An observational study of Hip Fractures, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Dietary pattern observed
- How many people
- 500,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2006to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Information on the UK Biobank cohort profile is available here: https://www.ukbiobank.ac.uk/
Who may be able to join
- Male or female
- Ages 40 to 70 years at time of recruitment
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Risk of Hip Fracture in Meat-eaters, Pescatarians, and Vegetarians in the UK Biobank
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.
Read the detailed description
Background:
Hip fracture is an increasingly prevalent health problem in the UK and worldwide that increases morbidity and mortality. Previous epidemiological evidence suggests that compared to meat-eaters, people following plant-based diets have lower bone mineral density (BMD) and a higher risk of fractures. Emerging evidence suggests a higher risk of hip fracture in vegetarian women, but prospective evidence of hip fracture risk in these diet groups is scarce and limited, particularly in men. Risk differences between diet groups are plausible in men and women, for example due to bone or muscle-related nutrient deficiencies or low BMI in vegetarians, but underlying mechanisms explaining potential risk differences require further investigation.
This study aims to investigate risk of hip fracture in occasional meat-eaters, pescatarians, and vegetarians compared to regular meat-eaters in the UK Biobank cohort. A secondary aim is to determine the role of potential modifying factors on associations between each diet group and hip fracture risk, including diet quality (determined by adherence to the Alternative Healthy Eating Index, AHEI), age, sex, and BMI, as well as investigating interactions between diet groups and genotypes on BMD and hip fracture risk. Thirdly, we aim to determine the role of potential mediating factors on any observed associations, including BMI, BMD, and intake of dietary nutrients abundant in animal products.
Research plan and methods:
The investigators will utilise dietary and lifestyle data from the UK Biobank cohort, which recruited over 500,000 adults between 2006-2010, and linked hospital records of UK Biobank participants to identify hip fracture cases.
A Cox regression model will be applied to investigate risk of hip fracture in each diet group compared to regular meat-eaters, and will be adjusted for relevant confounders. The roles of age, sex, AHEI score, BMI, and diet-gene interactions as potential effect modifiers will be explored by adding each variable to Cox regression models as interaction terms. Causal mediation analysis will be used to determine the role of potential mediators.
- Conditions
- Hip Fractures
- Being tested
- Dietary pattern observed
- Keywords
- Nutrition, Vegetarian, Fracture, Cohort study, Epidemiology, Osteoporosis
- Medical subject headings
- Hip Fractures, Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary pattern observedOther
Dietary pattern: regular meat-eater, occasional meat-eater, pescatarian, and vegetarian. There are no interventions in this observational cohort.
| Study group | Role | What they receive |
|---|---|---|
| UK Biobank | UK Biobank. There are no interventions in this observational cohort study. Receives: Other: Dietary pattern observed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip fracture incidence (first)
First incidence of hip fracture, identified from all relevant ICD diagnosis codes and treatment codes identified through linked HES data.
Measured: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2021).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Jan 2006
- Primary completion30 Sep 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Greenwood, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554549
- Sponsor's protocol ID
- 88995
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).
Publications
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.
PubMed 37501206
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Hip Fracture in Meat-eaters, Pescatarians, and Vegetarians in the UK Biobank
- ClinicalTrials.gov ID
- NCT05554549
- Acronym / sponsor ID
- 88995
- Conditions
- Hip Fractures
- Keywords
- Nutrition, Vegetarian, Fracture, Cohort study, Epidemiology, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Hip fracture is an increasingly prevalent health problem in the UK and worldwide that increases morbidity and mortality. Previous epidemiological evidence suggests that compared to meat-eaters, people following plant-based diets have lower bone mineral density (BMD) and a higher risk of fractures. Emerging evidence suggests a higher risk of hip fracture in vegetarian women, but prospective evidence of hip fracture risk in these diet groups is scarce and limited, particularly in men. Risk differences between diet groups are plausible in men and women, for example due to bone or muscle-related nutrient deficiencies or low BMI in vegetarians, but underlying mechanisms explaining potential risk differences require further investigation.
This study aims to investigate risk of hip fracture in occasional meat-eaters, pescatarians, and vegetarians compared to regular meat-eaters in the UK Biobank cohort. A secondary aim is to determine the role of potential modifying factors on associations between each diet group and hip fracture risk, including diet quality (determined by adherence to the Alternative Healthy Eating Index, AHEI), age, sex, and BMI, as well as investigating interactions between diet groups and genotypes on BMD and hip fracture risk. Thirdly, we aim to determine the role of potential mediating factors on any observed associations, including BMI, BMD, and intake of dietary nutrients abundant in animal products.
Research plan and methods:
The investigators will utilise dietary and lifestyle data from the UK Biobank cohort, which recruited over 500,000 adults between 2006-2010, and linked hospital records of UK Biobank participants to identify hip fracture cases.
A Cox regression model will be applied to investigate risk of hip fracture in each diet group compared to regular meat-eaters, and will be adjusted for relevant confounders. The roles of age, sex, AHEI score, BMI, and diet-gene interactions as potential effect modifiers will be explored by adding each variable to Cox regression models as interaction terms. Causal mediation analysis will be used to determine the role of potential mediators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UK Biobank | – | Other: Dietary pattern observedUK Biobank. There are no interventions in this observational cohort study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Information on the UK Biobank cohort profile is available here: https://www.ukbiobank.ac.uk/
Key inclusion criteria (3 listed)
- Male or female
- Ages 40 to 70 years at time of recruitment
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary pattern observedDietary pattern: regular meat-eater, occasional meat-eater, pescatarian, and vegetarian. There are no interventions in this observational cohort. | Other | UK Biobank |
Primary outcome
Hip fracture incidence (first)
Time frame: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2021).
First incidence of hip fracture, identified from all relevant ICD diagnosis codes and treatment codes identified through linked HES data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 37501206Webster 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.
- Individual participant dataSharing planned: No. IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip fracture incidence (first) (time frame: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2021).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05554549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.