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Plant-Based Diet for Patients With Rheumatoid Arthritis

NCT ID: NCT07268326

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Rheumatoid Arthritis (RA)

Keywords

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Rheumatoid Arthritis Plant-based Dietary intervention Clinical nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers
Project nurses

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Plant-based diet

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Plant-based diet

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role collaborator

Center for Clinical Research and Prevention

NETWORK

Sponsor Role lead

Responsible Party

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Allan Linneberg

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg and Frederiksberg Hospital, Center for Clinical Research and Prevention

Frederiksberg, , Denmark

Site Status RECRUITING

The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup

Glostrup Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Nikita Misella Hansen, Postdoc

Role: CONTACT

Phone: +4520661876

Email: [email protected]

Facility Contacts

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Nikita Misella Hansen, Postdoc

Role: primary

Role: backup

Nikita Misella Hansen, Postdoc

Role: primary

Other Identifiers

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H-25045516

Identifier Type: -

Identifier Source: org_study_id