Rheumatoid Arthritis (RA)NCT07268326
Plant-Based Diet for Patients With Rheumatoid Arthritis
A study testing Plant-based diet in people with Rheumatoid Arthritis (RA), run by Center for Clinical Research and Prevention at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity. The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in: Disease activity (measured by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Plant-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Dec 2025to Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- DAS28 score ≤3.2, and without swollen joints
- RA diagnosis of minimum one year
- Stable pharmacological treatment for at least four months and with no planned change in treatment within eight weeks
Who cannot join
- Smokers
- Diabetes mellitus
- Pregnancy / planned pregnancy
- Prednisolone treatment
- DAS28 above 3.2
- Current dietary habits resembling intervention diet (e.g., PBD lifestyle)
- Food allergies and intolerances
- Unable to understand the informed consent and study procedures
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg and Frederiksberg Hospital, Center for Clinical Research and Prevention
Frederiksberg
Nikita Misella Hansen, Postdoc, +4520661876, nikita.misella.hansen@regionh.dk
allan.linneberg@regionh.dk
- Recruiting
The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup
Glostrup Municipality
Nikita Misella Hansen, Postdoc, +4520661876, nikita.misella.hansen@regionh.dk
About this study
Official title: PLATE: Health Effects of Plant-Based Diet in Patients With Rheumatoid Arthritis
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity.
The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in:
Read more
- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life.
The effects of the PBD will be compared to a habitual diet, that includes no dietary changes.
Participants in the intervention group will:
- Receive weekly delivery of food boxes which include plant-based food items
- Receive a daily multivitamin supplement
- Receive continuous dietetic guidance
- Participate in a practical cooking class to get an introduction to a PBD
- Participate in three online supervisions throughout the intervention period
Participants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.
Read the detailed description
Rheumatoid Arthritis (RA) is a chronic, autoimmune disease, requiring lifelong medical treatment. Evidence has suggested that supporting patients with RA to take an active role in their management of their disease can improve the patients' overall health and quality of life. In addition, patients often ask for support to identify effective ways to reduce symptoms, which include lifestyle changes, of which nutrition may be important. From a patient perspective, the lack of consistent evidence on nutrition also affects patients' choices regarding diet. Patients with RA have expressed that their is insufficient guiding regarding dietary choices. Hypotheses about the effect of various diets on disease activity in RA have been suggested, hence, the influence of pro-inflammatory and anti-inflammatory ingredients have been clinically investigated, however, with very limited studies investigating the effect of a 100% plant-based diet (PBD) on disease activity in RA.
The objective of this study is to investigate if 16-weeks of PBD reduces disease activity and RA-related symptoms, and improves cardio-metabolic health, physical function, mental health, sleep quality and health-related quality of life (HRQoL) in patients with RA.
Thus, in this RCT the patients in the intervention group will be instructed to adhere to a 100% PBD and without changing e.g., exercise habits.
The 16-week intervention consists of
- Weekly delivery of food boxes including plant-based food items for the entire household. Including various different recipes for a balanced PBD.
- A daily multivitamin supplement.
- Continuous dietetic guidance either in person, by phone or e-mail.
- The patients will participate in a practical cooking class to get an introduction to a PBD. Here they will be in groups of approx. 5-8 patients.
- Throughout the intervention period the patients will in addition participate in three online supervisions with the same group they were together with in the cooking class.
- The patients will register their food and drink intake two days before each project visit.
The control group will be asked to maintain habitual diet. At study end, they will receive the same recipes as the intervention group.
All participants, despite group allocation will undergo the same outcome assessments at each project visits (baseline, week 6, week 12, week 16 (end of intervention), and a follow-up visit 12 months after end of intervention:
The following data will be collected:
Baseline:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records
Week 6 and 12:
- Blood samples
- Urine samples
- Dietary records
Week 16:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records 1-year follow-up:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Plant-based diet
- Keywords
- Rheumatoid Arthritis, Plant-based, Dietary intervention, Clinical nutrition
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietOther
The intervention is a 100% plant-based diet, and a daily multivitamin supplement. Participants in the intervention group will receive weekly food delivery to their household. Moreover, they will participate in a practical cooking workshop with other participants of the intervention group. Furthermore, they will have three online supervisions with relevant project staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Plant-based diet |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity measured by DAS28
The Disease Activity Score 28 (DAS28) is a composite index used to assess disease activity in patients with rheumatoid arthritis. The DAS28 is a quantification of tender and swollen joints within the hands, shoulders, elbows, wrists, and knees. These assessments, in conjunction with CRP values obtained from blood samples and the self-reported global Visual Analog Scale (VAS) score, will be incorporated into the computation of DAS28. The DAS28 ranges from 0 to 10, with higher scores indicating higher disease activity.
Measured: 16 weeks
Secondary outcomes (1)
Ultrasound - supportive of the primary outcome
Ultrasound is performed bilaterally of the radio-carpal, inter-carpal and radio-ulna joint (with the highest of the 3 scores as the final score for the wrist joint), 1-5 metacarpophalangeal joint (MCP), 2-5 proximal interphalangeal joint (PIP), interphalangeal joint, ankle joint and 2-5 metatarsophalangeal joint (MTP).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Allan Linneberg, Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268326
- Sponsor's protocol ID
- H-25045516
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLATE: Health Effects of Plant-Based Diet in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07268326
- Acronym / sponsor ID
- H-25045516
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Plant-based, Dietary intervention, Clinical nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Dec 2025 (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.
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity.
The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in:
- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life.
The effects of the PBD will be compared to a habitual diet, that includes no dietary changes.
Participants in the intervention group will:
- Receive weekly delivery of food boxes which include plant-based food items
- Receive a daily multivitamin supplement
- Receive continuous dietetic guidance
- Participate in a practical cooking class to get an introduction to a PBD
- Participate in three online supervisions throughout the intervention period
Participants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.
Detailed description
Rheumatoid Arthritis (RA) is a chronic, autoimmune disease, requiring lifelong medical treatment. Evidence has suggested that supporting patients with RA to take an active role in their management of their disease can improve the patients' overall health and quality of life. In addition, patients often ask for support to identify effective ways to reduce symptoms, which include lifestyle changes, of which nutrition may be important. From a patient perspective, the lack of consistent evidence on nutrition also affects patients' choices regarding diet. Patients with RA have expressed that their is insufficient guiding regarding dietary choices. Hypotheses about the effect of various diets on disease activity in RA have been suggested, hence, the influence of pro-inflammatory and anti-inflammatory ingredients have been clinically investigated, however, with very limited studies investigating the effect of a 100% plant-based diet (PBD) on disease activity in RA.
The objective of this study is to investigate if 16-weeks of PBD reduces disease activity and RA-related symptoms, and improves cardio-metabolic health, physical function, mental health, sleep quality and health-related quality of life (HRQoL) in patients with RA.
Thus, in this RCT the patients in the intervention group will be instructed to adhere to a 100% PBD and without changing e.g., exercise habits.
The 16-week intervention consists of
- Weekly delivery of food boxes including plant-based food items for the entire household. Including various different recipes for a balanced PBD.
- A daily multivitamin supplement.
- Continuous dietetic guidance either in person, by phone or e-mail.
- The patients will participate in a practical cooking class to get an introduction to a PBD. Here they will be in groups of approx. 5-8 patients.
- Throughout the intervention period the patients will in addition participate in three online supervisions with the same group they were together with in the cooking class.
- The patients will register their food and drink intake two days before each project visit.
The control group will be asked to maintain habitual diet. At study end, they will receive the same recipes as the intervention group.
All participants, despite group allocation will undergo the same outcome assessments at each project visits (baseline, week 6, week 12, week 16 (end of intervention), and a follow-up visit 12 months after end of intervention:
The following data will be collected:
Baseline:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records
Week 6 and 12:
- Blood samples
- Urine samples
- Dietary records
Week 16:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records 1-year follow-up:
- Assessment of swollen and tender joints
- Ultrasound of joints
- Patient-reported outcomes (questionnaires)
- Blood samples
- Urine samples
- Feces samples
- Blood pressure
- Anthropometrics (body composition)
- Dietary records
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Plant-based diet |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- DAS28 score ≤3.2, and without swollen joints
- RA diagnosis of minimum one year
- Stable pharmacological treatment for at least four months and with no planned change in treatment within eight weeks
Key exclusion criteria (8 listed)
- Smokers
- Diabetes mellitus
- Pregnancy / planned pregnancy
- Prednisolone treatment
- DAS28 above 3.2
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 |
|---|---|---|
| Plant-based dietThe intervention is a 100% plant-based diet, and a daily multivitamin supplement. Participants in the intervention group will receive weekly food delivery to their household. Moreover, they will participate in a practical cooking workshop with other participants of the intervention group. Furthermore, they will have three online supervisions with relevant project staff. | Other | Intervention group |
Primary outcome
Disease activity measured by DAS28
Time frame: 16 weeks
The Disease Activity Score 28 (DAS28) is a composite index used to assess disease activity in patients with rheumatoid arthritis. The DAS28 is a quantification of tender and swollen joints within the hands, shoulders, elbows, wrists, and knees. These assessments, in conjunction with CRP values obtained from blood samples and the self-reported global Visual Analog Scale (VAS) score, will be incorporated into the computation of DAS28. The DAS28 ranges from 0 to 10, with higher scores indicating higher disease activity.
1 secondary outcome
Ultrasound - supportive of the primary outcome
Time frame: 16 weeks
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet in people with Rheumatoid Arthritis (RA), run by Center for Clinical Research and Prevention at 2 sites in Denmark.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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?
Contact Nikita Misella Hansen, Postdoc (+4520661876, nikita.misella.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity measured by DAS28 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.