Clinical trial NCT04262505: A MEDiterranean Diet in Rheumatoid Arthritis
Official title: A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Mediterranean diet
Randomised controlled trial
Ireland
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mediterranean diet vs. Irish healthy eating guidelines
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Quality of Life
timeFrame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
measure: Changes in Physical Function
timeFrame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Secondary outcomes:
measure: Change in Diet adherence
timeFrame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
measure: Change in Physical activity levels
timeFrame: Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: Unievrsity of Limerick
name: Audrey Tierney
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.