Based on the recognition of the potential health benefits of the Mediterranean diet (MedDiet) in the scientific literature as well as in clinical settings, a proposed study to be published in Contemporary Clinical Trials Communications aims to assess the efficacy of Mediterranean dietary intervention for adults with rheumatoid arthritis (RA).
In this parallel-group, randomized controlled trial, a total of 44 participants aged 18 years or older with a definite diagnosis of RA will be assigned to the MedDiet group or the Irish Healthy Eating Guidelines group. Participants from both groups will follow dietary guidance with the study’s registered dietitian (RD) in 5 teleconsultations during the 12-week intervention period. During the baseline teleconsultation, the RD will explain how to follow the assigned dietary pattern to participants in each group. At weeks 3 and 9, the RD will monitor participants’ adherence to the assigned diet using a 24-hour recall. Primary outcome measures include change in participants’ quality of life (using the Rheumatoid Arthritis Quality of Life instrument) and physical functioning (using the Yale Physical Activity Survey).
Limitations of this study include an intervention period that is of short duration compared with other dietary interventions and small sample size. Potential selection bias must be evaluated due to the recruitment of participants through social media platforms. Finally, although the primary outcome measures are clinically relevant, they are based on recollection and subjective measures.
The study authors noted, “To our best knowledge, [this] study is the first randomized controlled trial assessing the effect of a MedDiet in an Irish population. The [study] will provide evidence as to whether a dietary intervention can improve quality of life and physical function of adults living with RA in Ireland. This, in turn, [infers] the potential translation to other inflammatory conditions.”
Raad T, George E, Griffin A, et al. A randomised controlled trial of a Mediterranean dietary intervention for adults with rheumatoid arthritis (MEDRA): study protocol. Contemp Clin Trials Commun. Published online May 3, 2022. doi:10.1016/j.conctc.2022.100919