Rheumatoid Arthritis (RA)NCT06670183
Dietary Factors and Rheumatoid Arthritis Risk in the UK Biobank
An observational study of Rheumatoid Arthritis (RA), run by University of Leeds.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Dietary patterns, Food groups and Nutrients and Alcohol intake
- How many people
- 500,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: General 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 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)
About this study
Official title: The Associations Between Diet and Rheumatoid Arthritis Risk in the UK Biobank
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Dietary patterns, Food groups and Nutrients, Alcohol intake, Vitamin D status
- Keywords
- Nutrition, Rheumatoid Arthritis, Body Mass Index, Alcohol consumption, Cohort study, Epidemiology, Arthritis, Rheumatoid, Seropostive
- Medical subject headings
- Arthritis, Rheumatoid, Alcohol Drinking, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary patternsOther
Dietary patterns such as regular meat-eater, occasional meat-eater, pescatarian, and vegetarian; Mediterranean diet.
Food groups and NutrientsOther
Dietary components, such as oily fish, dairy product, supplements, fibre, vitamin D supplements.
Alcohol intakeOther
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.
Vitamin D statusOther
Serum 25(OH)D was measured once at baseline through a non-fasted blood draw during any season of the year.
| Study group | Role | What they receive |
|---|---|---|
| UK Biobank | UK Biobank. There are no interventions in this observational cohort study. Receives: Other: Dietary patterns; Other: Food groups and Nutrients; Other: Alcohol intake; Other: Vitamin D status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis incidence (first)
First RA incidence, identified from all relevant ICD diagnosis codes and treatment codes identified through linked HES data.
Measured: Time Frame: Age when the completed questionnaire was returned (2006-2010) until age at event, death, or end of study period (2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jan 2006
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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 Rheumatoid Arthritis (RA)Studies 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
- Investigators
- Darren C Greenwood, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670183
- Sponsor's protocol ID
- fsydo_UKBB
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD from UK Biobank is available to genuine researchers on application (https://www.ukbiobank.ac.uk/enable-your-research/apply-for-access).
Publications
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.
PubMed 25826379
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Between Diet and Rheumatoid Arthritis Risk in the UK Biobank
- ClinicalTrials.gov ID
- NCT06670183
- Acronym / sponsor ID
- fsydo_UKBB
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Nutrition, Rheumatoid Arthritis, Body Mass Index, Alcohol consumption, Cohort study, Epidemiology, Arthritis, Rheumatoid, Seropostive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Nov 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UK Biobank | – | Other: Dietary patterns, Other: Food groups and Nutrients, Other: Alcohol intake, Other: Vitamin D statusUK 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
- General 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 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)
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 patternsDietary patterns such as regular meat-eater, occasional meat-eater, pescatarian, and vegetarian; Mediterranean diet. | Other | UK Biobank |
| Food groups and NutrientsDietary components, such as oily fish, dairy product, supplements, fibre, vitamin D supplements. | Other | UK Biobank |
| Alcohol intakeFrequency 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. | Other | UK Biobank |
| Vitamin D statusSerum 25(OH)D was measured once at baseline through a non-fasted blood draw during any season of the year. | Other | UK Biobank |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 25826379Sudlow 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Darren C Greenwood, PhD principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by University of Leeds.
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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
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).). 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 NCT06670183, 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 1 May 2026.