Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05554549 |
| Other study ID # |
88995 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2006 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Leeds |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
