NCT06670183

Brief Summary

Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting around 1% of the UK population. It affects around 400,000 adults and is characterised by synovial inflammation, cartilage and bone damage that requires lifelong treatment and represents a significant burden for both the individual and society. Diet can affect inflammatory status and RA risk, with varying risks for men and women on specific diets. People with low to moderate consumption of alcohol may be at a lower risk of RA. Those who consume lower intakes of fruit and vegetables could be at a greater risk than those with adequate intakes. This research aims to better understand the role of diet in reducing RA risk in men and women in the United Kingdom. The research will use existing dietary and lifestyle data from the United Kingdom Biobank Study and hospital records of RA incidence.

Trial Health

83
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
44mo left

Started Jan 2006

Longer than P75 for all trials

Status
active not recruiting

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 Progress85%
Jan 2006Dec 2029

Study Start

First participant enrolled

January 1, 2006

Completed
18.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

24 years

First QC Date

October 31, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

NutritionRheumatoid ArthritisBody Mass IndexAlcohol consumptionCohort studyEpidemiologyArthritis, Rheumatoid, Seropostive

Outcome Measures

Primary Outcomes (1)

  • Rheumatoid Arthritis incidence (first)

    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).

Study Arms (1)

UK Biobank

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

Other: Dietary patternsOther: Food groups and NutrientsOther: Alcohol intakeOther: Vitamin D status

Interventions

Dietary patterns such as regular meat-eater, occasional meat-eater, pescatarian, and vegetarian; Mediterranean diet.

UK Biobank

Dietary components, such as oily fish, dairy product, supplements, fibre, vitamin D supplements.

UK Biobank

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.

UK Biobank

Serum 25(OH)D was measured once at baseline through a non-fasted blood draw during any season of the year.

UK Biobank

Eligibility Criteria

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

General 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sudlow C, Gallacher J, Allen N, Beral V, Burton P, Danesh J, Downey P, Elliott P, Green J, Landray M, Liu B, Matthews P, Ong G, Pell J, Silman A, Young A, Sprosen T, Peakman T, Collins R. UK biobank: an open access resource for identifying the causes of a wide range of complex diseases of middle and old age. PLoS Med. 2015 Mar 31;12(3):e1001779. doi: 10.1371/journal.pmed.1001779. eCollection 2015 Mar.

    PMID: 25826379BACKGROUND

Related Links

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

Arthritis, RheumatoidAlcohol DrinkingArthritis

Interventions

Dietary PatternsNutrientsEthanol

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFeeding BehaviorFoodFood and BeveragesAlcoholsOrganic Chemicals

Study Officials

  • Darren C Greenwood, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

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

October 31, 2024

First Posted

November 1, 2024

Study Start

January 1, 2006

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).
Access Criteria
IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).
More information

Available IPD Datasets

Individual Participant Data Set Access