Rheumatoid ArthritisNCT04262505
A MEDiterranean Diet in Rheumatoid Arthritis
A study testing Mediterranean Diet Group and Healthy Eating Group in people with Rheumatoid Arthritis, run by University of Limerick at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Mediterranean Diet Group and Healthy Eating Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIreland
- Study dates
- 6 Feb 2020to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year
- Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria
- Full access to Internet/smartphone
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)
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.
Read the 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
- Being tested
- Mediterranean Diet Group, Healthy Eating Group
- Keywords
- Mediterranean diet, Randomised controlled trial, Ireland
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet GroupBehavioural
Participants will be advised to follow a traditional Mediterranean diet
Healthy Eating GroupBehavioural
Participants will be advised to follow the Healthy Eating Guidelines in Ireland
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Group (Group A) | Experimental | 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. Receives: Behavioral: Mediterranean Diet Group |
| Healthy Eating Group (Group B) | Experimental | 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. Receives: Behavioral: Healthy Eating Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
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.
Measured: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Secondary outcomes (2)
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
Measured: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Change in Physical activity levels
Assessment of participants' physical activity levels using the YPAS (Yale Physical activity survey)
Measured: Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start6 Feb 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Mediterranean diet vs. Irish healthy eating guidelines
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tala Raad, University of Limerick
- Investigators
- Audrey Tierney, Principal investigator, Unievrsity of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262505
- Sponsor's protocol ID
- MEDRA
- Status last verified
- May 2022
- First submitted
- 4 Feb 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39112976Raad 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.
PubMed 35620325
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)
- ClinicalTrials.gov ID
- NCT04262505
- Acronym / sponsor ID
- MEDRA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Mediterranean diet, Randomised controlled trial, Ireland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 10 Feb 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mediterranean diet vs. Irish healthy eating guidelines
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Group (Group A) | Experimental | Behavioral: Mediterranean Diet GroupThe 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. |
| Healthy Eating Group (Group B) | Experimental | Behavioral: Healthy Eating GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 year
- Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria
- Full access to Internet/smartphone
- English speaking
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Mediterranean Diet GroupParticipants will be advised to follow a traditional Mediterranean diet | Behavioural | Mediterranean Diet Group (Group A) |
| Healthy Eating GroupParticipants will be advised to follow the Healthy Eating Guidelines in Ireland | Behavioural | Healthy Eating Group (Group B) |
Primary outcome
Changes in Quality of Life
Time frame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
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.
Changes in Physical Function
Time frame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
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.
2 secondary outcomes
Change in Diet adherence
Time frame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)
Change in Physical activity levels
Time frame: Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 39112976Raad 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.
- Derived from this study: PubMed 35620325Raad 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Audrey Tierney principal investigator
Unievrsity of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Group and Healthy Eating Group in people with Rheumatoid Arthritis, run by University of Limerick at 1 site in Ireland.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 17 May 2022. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Quality of Life (time frame: Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262505, which also lists 2 linked publications.
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 17 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.