A MEDiterranean Diet in Rheumatoid Arthritis

NCT ID: NCT04262505

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2021-10-06

Brief Summary

The MEDRA study is a 12-week randomised controlled trial that aims to assess effects of a Mediterranean dietary telehealth intervention compared to the Irish Healthy Eating guidelines on the physical function and quality of life of adults living with Rheumatoid Arthritis in Ireland. Investigators will be able to determine how closely people living in Ireland can accept the Mediterranean dietary practices and adhere to them with dietetic input and guidance.

Detailed Description

Rheumatoid arthritis (RA) is a long-term inflammatory disease which commonly occurs in the small joints of the hands, wrists and feet leading to swelling, pain and stiffness in the affected joints. The condition is two to three times more prevalent in women than in men. Although it might occur at any age, the incidence of the disease is highest between the ages of 40 and 65 years. Currently, there is no treatment that provides complete remission of the disease for people living with RA. Treatment of RA aims to reduce the symptoms and improve the health of the patient. Although diet is not part of the mainstream treatment, many studies have reported beneficial effects of certain diets on RA symptoms. The MEDRA study will examine the habitual dietary intakes of people living with RA in Ireland and will explore whether people with RA will benefit from either a Mediterranean dietary pattern or the Healthy eating guidelines in Ireland. This small scale study will provide useful information on whether people with RA in Ireland can adhere to a Mediterranean dietary pattern and whether the intervention will have beneficial impact on the physical function and quality of life. This is important work prior to proceeding to larger intervention studies.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet Group (Group A)

The intervention is based on components of the traditional Mediterranean diet which is primarily a plant based diet and emphasises intakes of vegetables, whole grains and fruit with the main added fat being extra virgin olive oil.The diet will be modified and tailored to cultured preferences by the registered dietitian. Participants will be informed of their diet allocation group during the baseline teleconsultation and will commence the diet the following day or as soon as is feasible for 12 weeks. Participants will be provided with resources specifically designed to explain the components of the Mediterranean diet and how it will be followed.

Group Type: EXPERIMENTAL

Mediterranean Diet Group

Intervention Type: BEHAVIORAL

Participants will be advised to follow a traditional Mediterranean diet

Healthy Eating Group (Group B)

Participants assigned to the Healthy Eating group will be advised to adhere to the current healthy eating guidelines and will be provided with resources to inform them of these guidelines and sample meal plans that are readily available on the Healthy Ireland website.

Group Type: EXPERIMENTAL

Healthy Eating Group

Intervention Type: BEHAVIORAL

Participants will be advised to follow the Healthy Eating Guidelines in Ireland

Interventions

Mediterranean Diet Group

Participants will be advised to follow a traditional Mediterranean diet

Intervention Type: BEHAVIORAL

Healthy Eating Group

Participants will be advised to follow the Healthy Eating Guidelines in Ireland

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 year
• Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria
• Full access to Internet/smartphone
• English speaking

Exclusion Criteria

• Age <18 years
• Breastfeeding, pregnant or trying to get pregnant.
• Patients who have commenced nutritional supplements or a new dietary regime in the month prior to study enrolment.
• Patients who do not have access to the Internet/smartphone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Tala Raad

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Audrey Tierney

Role: PRINCIPAL_INVESTIGATOR

Unievrsity of Limerick

Locations

University Hospital Limerick

Limerick, , Ireland

Countries

Ireland

References

Raad T, George E, Griffin A, Larkin L, Fraser A, Kennedy N, Tierney A. Effects of a telehealth-delivered Mediterranean diet intervention in adults with Rheumatoid Arthritis (MEDRA): a randomised controlled trial. BMC Musculoskelet Disord. 2024 Aug 7;25(1):631. doi: 10.1186/s12891-024-07742-1.

Reference Type: DERIVED

PMID: 39112976 (View on PubMed)

Raad T, George E, Griffin A, Larkin L, Fraser A, Kennedy N, Tierney A. A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Rheumatoid Arthritis (MEDRA): Study protocol. Contemp Clin Trials Commun. 2022 May 3;28:100919. doi: 10.1016/j.conctc.2022.100919. eCollection 2022 Aug.

Reference Type: DERIVED

PMID: 35620325 (View on PubMed)

Other Identifiers

MEDRA

Identifier Type: -

Identifier Source: org_study_id