A MEDiterranean Diet in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262505
• Other study ID #: MEDRA
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: October 6, 2021

Study information

• Verified date: May 2022
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Mediterranean Diet Group
Participants will be advised to follow a traditional Mediterranean diet
• Healthy Eating Group
Participants will be advised to follow the Healthy Eating Guidelines in Ireland

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Life	Rheumatoid Arthritis Quality of Life questionnaire (RAQoL) will be used to describe the individuals' perceptions, satisfaction, and evaluation of different areas of their own lives, such as physical health and functioning, psychological and emotional well-being, social roles, and relationships. A scale 1 to 30 will be used whereby the higher the score, the worse the QoL.	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Primary	Changes in Physical Function	The health assessment questionnaire disability index (HAQ-DI) is an index used to assess how arthritis impacts the participant's everyday life. A scale 0-3 is used whereby 3 indicated very severe disability.	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Secondary	Change in Diet adherence	Assessment of participants' adherence to either the Mediterranean diet or the current Irish Healthy Guidelines will be assessed using a PREDIMED validated checklist and a Healthy Eating checklist respectively. Higher scores indicate greater adherence to the diet assigned. A 3-day food diary will also be used to captures the dietary intake of participants	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Secondary	Change in Physical activity levels	Assessment of participants' physical activity levels using the YPAS (Yale Physical activity survey)	Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)