Rheumatoid Arthritis (RA)NUTRANCT06831331
Nutrition in Rheumatoid Arthritis
A study testing Healthy diet based on NNR2023 in people with Rheumatoid Arthritis (RA), run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Background: Individuals with Rheumatoid Arthritis (RA) often experience persistent symptoms such as pain and stiffness despite modern pharmacological treatments. They also have an increased risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Healthy diet based on NNR2023
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2025to 31 Dec 2030
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed RA on Methotrexate and/or additional treatment. RA is defined according to the criteria from EULAR/American College of Rheumatology (ACR) 2010.
- BMI 18.5-40 kg/m2
- willing to follow the intervention diet
Who cannot join
- pregnancy
- lactation
- diagnosis for cancer or other life-threatening diseases
- diabetes type 1 and 2
- inflammatory bowel disease or celiac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University Hospital
Gothenburg, 405 30
About this study
Official title: NUTRA- Nutrition in Rheumatoid Arthritis
Background: Individuals with Rheumatoid Arthritis (RA) often experience persistent symptoms such as pain and stiffness despite modern pharmacological treatments. They also have an increased risk of cardiovascular disease. Elevated risk factors for cardiovascular disease limit the options for some symptom-relieving medications, making a reduction in these risk factors highly desirable. Diet has been shown to reduce several of these factors, but the scientific evidence for rheumatoid arthritis is limited, and thus tailored dietary advice is lacking.
Objective: The purpose of the NUTRA study is to evaluate the effect of a diet that follows the updated Nordic Nutrition Recommendations (2023) on disease activity and cardiovascular risk factors in individuals with diagnosed RA. Specifically, the study will analyze the impact of the diet on clinically relevant markers such as blood pressure, lipid profile, inflammatory markers, and body composition.
Read more
Study Plan: The study will include about 120 patients, and participants will be randomized into either an immediate 3-month diet intervention following the Nordic Nutrition recommendations or a waitinglist control group, that will start with the diet intervention after three months. The intervention diet, will be added as a complementary treatment to the medications the patients are already taking. Participants will receive menus, recipes and some foods for three months, followed by self-maintenance of the diet. Clinical markers will be evaluated before and after the intervention/control periods and six months after ending their intervention period. Primary outcome is ApoB.
The NUTRA study aims to generate evidence to guide the design of dietary interventions for patients with rheumatoid arthritis. By understanding the potential role of diet in reducing both disease activity and cardiovascular risk, the study may contribute to improved treatment strategies for this challenging patient group.
Read the detailed description
NUTRA population and recruitment. Approximately 120 women and men aged 18-85 years with diagnosed RA will be recruited in the Gothenburg region. Approximately 42-48 evaluable participants per randomized group provide 80% power to detect a 15% between-group difference in ApoB after three months at a two-sided α=0.05. Stable treatment and no planned changes in antirheumatic or lipid-affecting medication during the primary period limit pharmacological confounding. Recruitment follows established rheumatology pathways; detailed eligibility criteria are governed by the approved protocol.
Randomization and intervention. Participants are randomized to an immediate three-month intervention or a waiting-list control for three months before receiving the same dietary intervention. The intervention follows NNR2023 and combines food provision with structured, individualized support to facilitate sustainable change. The waiting-list design preserves a randomized comparison while ensuring that all participants are offered the intervention.
Data collection. Baseline and three-month assessments include fasting blood samples, clinical phenotype, blood pressure, joint examination, body composition by dual-energy X-ray absorptiometry, physical function and quality-of-life questionnaires, weighed dietary records and a Food Frequency Questionary (FFQ). Adherence is evaluated from dietary data and selected biomarkers. Samples are stored for metabolomics and inflammatory profiling. The simplified six-month after intervention end follow-up consists of fasting routine blood lipids only, minimizing participant burden while retaining a clinically meaningful maintenance outcome.
Outcomes and analysis. ApoB is the primary outcome. Secondary outcomes include LDL and HDL cholesterol, triglycerides, total cholesterol, disease activity measured by the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), and European Alliance of Associations for Rheumatology (EULAR) response and remission. Olink Target 96 Inflammation characterizes inflammatory profiles; metabolomics supports exploratory response and predictor analyses. The primary analysis follows intention-to-treat principles, comparing randomized groups at three months with baseline adjustment. Mixed-effects models will account for repeated measurements where appropriate. Inflammatory analyses will address multiple testing. Predictor analyses will be exploratory, with model complexity constrained by sample size and internal validation used to assess overfitting.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Healthy diet based on NNR2023, Control/waiting-list
- Keywords
- nutrition, diet, nordic nutrition recommendations, inflammation, metabolomics, cardiovascular risk factors
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy diet based on NNR2023Other
Personalized diet- the participants will get individual advice how to adapt their habitual diet to the Nordic Nutrition Recommendations 2023
Control/waiting-listOther
Habitual diet during the waiting-period/control followed by healthy diet based on NNR2023
| Study group | Role | What they receive |
|---|---|---|
| Immediate healthy diet intervention based on the NNR 2023 | Experimental | Diet following the Nordic Nutrition Recommendations 2023 Receives: Other: Healthy diet based on NNR2023 |
| Delayed dietary intervention based on the NNR2023 (waiting-list control) | Experimental | Habitual diet for 3 months followed by healthy diet based on NNR2023 for 3 months Receives: Other: Healthy diet based on NNR2023; Other: Control/waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apolipoprotein B
Measured: 3 months dietary intervention and at 9 months follow up
Secondary outcomes (13)
Patterns of serum inflammatory markers
Olink Target 96 Inflammation panel will be analysed and multivariate method (OPLS-DA) will be used to evaluate changes in the inflammatory markers between intervention and control.
Measured: 3 months dietary intervention
Remission yes/no
Based on disease activity score -28 joints-erythrocyte sediment rate (DAS28-ESR) and European League Against Rheumatism (EULAR) criteria
Measured: 3 months dietary intervention
Disease activity DAS28-CRP
based on disease activity score -28 joints-c-reactive protein (DAS28-CRP)
Measured: 3 months dietary intervention
triacylglycerides
Measured: 3 months dietary intervention and at 9 months follow up
high density lipoprotein
HDL
Measured: 3 months dietary intervention and at 9 months follow up
Low density lipoprotein (LDL)
Measured: 3 months dietary intervention and at 9 months follow up
total cholesterol
Measured: 3 months dietary intervention and at 9 months follow up
Erythrocyte sediment rate (ESR)
Measured: 3 months dietary intervention and at 9 months follow up
high sensitive-C-reactive protein (hs-CRP)
Measured: 3 months dietary intervention and at 9 months follow up
Corticosteroid use
Participants will note the use of corticosteroids. A decrease could indicate less pain. Changes is also important to adjust for in analysis of effects on inflammation markers.
Measured: 3 months dietary intervention and at 9 months follow up
Physical disability
Based on the questionnaire HAQ THE HEALTH ASSESSMENT QUESTIONNAIRE (HAQ) DISABILITY INDEX (DI) There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). Total score is divided to the number of categories and the range of the index is thus 0-3p.
Measured: 3 months dietary intervention and at 9 months follow up
Quality of life (RAND-SF36)
Self-reported quality of life based on the questionnaire 36-Item Short Form Survey Instrument (SF-36) from RAND (Research and Development- non profit organisation). It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scale is 0-100. Higher score indicates better quality of life.
Measured: 3 months dietary intervention and at 9 months follow up
Disease activity score DAS28-ESR
Disease activity score based on 28 joints and erythrocyte sediment rate (ESR)
Measured: 3 months dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wating-list parallel study. Participants will be randomized to a intervention or control/waitinglist period. Participants randomized to control/waitinglist will continue with intervention directly after their controlperiod.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831331
- Sponsor's protocol ID
- NUTRA
- Acronym
- NUTRA
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not eligible according to Swedish law
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRA- Nutrition in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06831331
- Acronym / sponsor ID
- NUTRA / NUTRA
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- nutrition, diet, nordic nutrition recommendations, inflammation, metabolomics, cardiovascular risk factors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Feb 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.
Background: Individuals with Rheumatoid Arthritis (RA) often experience persistent symptoms such as pain and stiffness despite modern pharmacological treatments. They also have an increased risk of cardiovascular disease. Elevated risk factors for cardiovascular disease limit the options for some symptom-relieving medications, making a reduction in these risk factors highly desirable. Diet has been shown to reduce several of these factors, but the scientific evidence for rheumatoid arthritis is limited, and thus tailored dietary advice is lacking.
Objective: The purpose of the NUTRA study is to evaluate the effect of a diet that follows the updated Nordic Nutrition Recommendations (2023) on disease activity and cardiovascular risk factors in individuals with diagnosed RA. Specifically, the study will analyze the impact of the diet on clinically relevant markers such as blood pressure, lipid profile, inflammatory markers, and body composition.
Study Plan: The study will include about 120 patients, and participants will be randomized into either an immediate 3-month diet intervention following the Nordic Nutrition recommendations or a waitinglist control group, that will start with the diet intervention after three months. The intervention diet, will be added as a complementary treatment to the medications the patients are already taking. Participants will receive menus, recipes and some foods for three months, followed by self-maintenance of the diet. Clinical markers will be evaluated before and after the intervention/control periods and six months after ending their intervention period. Primary outcome is ApoB.
The NUTRA study aims to generate evidence to guide the design of dietary interventions for patients with rheumatoid arthritis. By understanding the potential role of diet in reducing both disease activity and cardiovascular risk, the study may contribute to improved treatment strategies for this challenging patient group.
Detailed description
NUTRA population and recruitment. Approximately 120 women and men aged 18-85 years with diagnosed RA will be recruited in the Gothenburg region. Approximately 42-48 evaluable participants per randomized group provide 80% power to detect a 15% between-group difference in ApoB after three months at a two-sided α=0.05. Stable treatment and no planned changes in antirheumatic or lipid-affecting medication during the primary period limit pharmacological confounding. Recruitment follows established rheumatology pathways; detailed eligibility criteria are governed by the approved protocol.
Randomization and intervention. Participants are randomized to an immediate three-month intervention or a waiting-list control for three months before receiving the same dietary intervention. The intervention follows NNR2023 and combines food provision with structured, individualized support to facilitate sustainable change. The waiting-list design preserves a randomized comparison while ensuring that all participants are offered the intervention.
Data collection. Baseline and three-month assessments include fasting blood samples, clinical phenotype, blood pressure, joint examination, body composition by dual-energy X-ray absorptiometry, physical function and quality-of-life questionnaires, weighed dietary records and a Food Frequency Questionary (FFQ). Adherence is evaluated from dietary data and selected biomarkers. Samples are stored for metabolomics and inflammatory profiling. The simplified six-month after intervention end follow-up consists of fasting routine blood lipids only, minimizing participant burden while retaining a clinically meaningful maintenance outcome.
Outcomes and analysis. ApoB is the primary outcome. Secondary outcomes include LDL and HDL cholesterol, triglycerides, total cholesterol, disease activity measured by the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), and European Alliance of Associations for Rheumatology (EULAR) response and remission. Olink Target 96 Inflammation characterizes inflammatory profiles; metabolomics supports exploratory response and predictor analyses. The primary analysis follows intention-to-treat principles, comparing randomized groups at three months with baseline adjustment. Mixed-effects models will account for repeated measurements where appropriate. Inflammatory analyses will address multiple testing. Predictor analyses will be exploratory, with model complexity constrained by sample size and internal validation used to assess overfitting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Wating-list parallel study. Participants will be randomized to a intervention or control/waitinglist period. Participants randomized to control/waitinglist will continue with intervention directly after their controlperiod.
| Arm | Type | Receives |
|---|---|---|
| Immediate healthy diet intervention based on the NNR 2023 | Experimental | Other: Healthy diet based on NNR2023Diet following the Nordic Nutrition Recommendations 2023 |
| Delayed dietary intervention based on the NNR2023 (waiting-list control) | Experimental | Other: Healthy diet based on NNR2023, Other: Control/waiting-listHabitual diet for 3 months followed by healthy diet based on NNR2023 for 3 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed RA on Methotrexate and/or additional treatment. RA is defined according to the criteria from EULAR/American College of Rheumatology (ACR) 2010.
- BMI 18.5-40 kg/m2
- willing to follow the intervention diet
Key exclusion criteria (5 listed)
- pregnancy
- lactation
- diagnosis for cancer or other life-threatening diseases
- diabetes type 1 and 2
- inflammatory bowel disease or celiac disease
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 |
|---|---|---|
| Healthy diet based on NNR2023Personalized diet- the participants will get individual advice how to adapt their habitual diet to the Nordic Nutrition Recommendations 2023 | Other | Delayed dietary intervention based on the NNR2023 (waiting-list control), Immediate healthy diet intervention based on the NNR 2023 |
| Control/waiting-listHabitual diet during the waiting-period/control followed by healthy diet based on NNR2023 | Other | Delayed dietary intervention based on the NNR2023 (waiting-list control) |
Primary outcome
Apolipoprotein B
Time frame: 3 months dietary intervention and at 9 months follow up
13 secondary outcomes
Patterns of serum inflammatory markers
Time frame: 3 months dietary intervention
Remission yes/no
Time frame: 3 months dietary intervention
Disease activity DAS28-CRP
Time frame: 3 months dietary intervention
triacylglycerides
Time frame: 3 months dietary intervention and at 9 months follow up
high density lipoprotein
Time frame: 3 months dietary intervention and at 9 months follow up
Low density lipoprotein (LDL)
Time frame: 3 months dietary intervention and at 9 months follow up
total cholesterol
Time frame: 3 months dietary intervention and at 9 months follow up
Erythrocyte sediment rate (ESR)
Time frame: 3 months dietary intervention and at 9 months follow up
high sensitive-C-reactive protein (hs-CRP)
Time frame: 3 months dietary intervention and at 9 months follow up
Corticosteroid use
Time frame: 3 months dietary intervention and at 9 months follow up
Physical disability
Time frame: 3 months dietary intervention and at 9 months follow up
Quality of life (RAND-SF36)
Time frame: 3 months dietary intervention and at 9 months follow up
Disease activity score DAS28-ESR
Time frame: 3 months dietary intervention
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 23 Oct 2026.
- Information about the study for presumptive participants- IN SWEDISHLink provided by the sponsor.
- About this study and previous studies within the same research area- IN SWEDISHLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not eligible according to Swedish law
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy diet based on NNR2023 in people with Rheumatoid Arthritis (RA), run by Vastra Gotaland Region at 1 site in Sweden.
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: enrolling by invitation, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
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?
Apolipoprotein B (time frame: 3 months dietary intervention and at 9 months follow up). 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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.