- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670183
Dietary Factors and Rheumatoid Arthritis Risk in the UK Biobank
The Associations Between Diet and Rheumatoid Arthritis Risk in the UK Biobank
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
RA is the most common inflammatory arthritis in the United Kingdom, contributing significantly to increased morbidity and mortality, particularly from cardiovascular diseases. Epidemiological evidence suggests that compared to occasional drinkers, moderate alcohol consumption may reduce RA risk compared to non-drinkers, and occasional drinking. Additionally, observational research highlights the potential for RA risk reduction through dietary modifications, though evidence on interactions between dietary and genetic factors remains limited, particularly in prospective cohort studies. Moreover, the mechanisms underlying potential differences in RA risk between men and women are not yet fully understood.
This study aims to assess the associations between dietary factors, such as alcohol consumption and dietary patterns, and RA incidence within the UK Biobank cohort. A secondary objective is to evaluate the role of potential modifiers in the relationship between dietary factors and RA risk, including adherence to the Alternative Healthy Eating Index (AHEI), Townsend index, as well as age, sex, body mass index (BMI), smoking status, and physical activity. Additionally, interactions between dietary factors and genetic profiles in relation to RA risk will be investigated.
Research plan and methods:
This study will utilize dietary and lifestyle data from the UK Biobank, a cohort that recruited over 500,000 adults from 2006 to 2010, and linked hospital records to identify incident RA cases.
Cox proportional hazards regression models will be employed to examine associations between dietary factors and RA incidence, adjusting for relevant confounders. Potential effect modifiers such as age, sex, AHEI score, Townsend index, BMI, smoking status, physical activity, and gene-diet interactions will be analyzed by including interaction terms in the Cox models. Causal mediation analysis will further clarify the role of potential mediators. Additionally, inflammatory and immune-related factors, metabolic profile, and genetic susceptibility will be assessed to explore their contributions to RA risk.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female
- Ages 40 to 70 years at time of recruitment
- Able to provide informed consent
Exclusion Criteria:
- Unable to link dietary and lifestyle data with hospital episode statistics
- Had a rheumatoid arthritis 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
UK Biobank
UK Biobank.
There are no interventions in this observational cohort study.
|
Dietary patterns such as regular meat-eater, occasional meat-eater, pescatarian, and vegetarian; Mediterranean diet.
Dietary components, such as oily fish, dairy product, supplements, fibre, vitamin D supplements.
Frequency and intake of alcoholic beverages was measured by self-reporting the weekly frequency of different types of alcoholic beverages, e.g., the number of pints of beer/cider consumed per week and measures of spirits or liquors consumed per week were collected to assess consumption of beer/cider and spirits.
Serum 25(OH)D was measured once at baseline through a non-fasted blood draw during any season of the year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rheumatoid Arthritis incidence (first)
Time Frame: Time Frame: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2024).
|
First RA incidence, identified from all relevant ICD diagnosis codes and treatment codes identified through linked HES data.
|
Time Frame: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2024).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Darren C Greenwood, PhD, University of Leeds
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Drinking Behavior
- Behavior
- Skin and Connective Tissue Diseases
- Arthritis
- Alcohol Drinking
- Arthritis, Rheumatoid
- Organic Chemicals
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Nutritional Physiological Phenomena
- Alcohols
- Diet
- Feeding Behavior
- Ethanol
- Nutrients
- Dietary Patterns
Other Study ID Numbers
- fsydo_UKBB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Study Data/Documents
-
Individual Participant Data Set
Information comments: Apply for access to UK Biobank
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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