Rheumatoid Arthritis Clinical Trial
Official title:
Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis: a Randomized Controlled Trial
Aim of the present study was to evaluate the effect of different lifestyle intervention administrations, in increasing adherence to the Mediterranean diet in a group of patients with RA living in the Mediterranean basin, and, thus, in improving parameters related to subjective and objective disease markers, including plasma adiponectin concentrations.
The effect of various dietary regimens and nutrient supplementation on rheumatoid arthritis
(RA) has been previously explored, with the majority of the evidence supporting the
beneficial effect of n-3 polyunsaturated fatty acids (PUFAs), consumed mainly as fish oil
supplements. However, many capsules should be taken on a daily basis (10 - 15) in order to
improve health status, increasing, thus, the high drug burden these patients may encounter;
inability to comply with supplementation, as depicted in drop-out rates and adverse
reactions, is also of concern. On the other hand, the so far investigation of specific
dietary patterns, namely elemental or vegetarian diets, revealed similar limitations
regarding inability to comply, without producing clear benefit.
The last decade, a traditional dietary pattern, the Mediterranean diet, has also been
investigated in patients with RA. This pattern is characterized by abundance of plant foods
(fruits, mainly as typical daily desserts, vegetables, bread, other forms of cereals, beans,
nuts, and seeds), olive oil as the principal source of fat, moderate amounts of dairy
products (mainly cheese and yogurt), low to moderate amounts of fish and poultry, red meat
in low amounts and wine consumed in moderation, normally with meals. Adherence to the
Mediterranean diet has been associated with a significant reduction in total mortality and
improvement in longevity, as well as with lower incidence of atherosclerosis, coronary heart
disease, metabolic syndrome and biochemical markers related to insulin resistance and
inflammation. In RA, in specific, it has been shown to improve objective and subjective
measures. It is also worth mentioning that this type of intervention produced negligible or
no adverse effects or drop-out in RA patients. However, it has been implemented in
North-European populations with a background diet far away from the Mediterranean dietary
habits. It would be interesting to study the effect of a Mediterranean diet-based
intervention in a Mediterranean population of RA patients, evaluate their adherence and
changes in subjective disease measures as well as in biochemical markers. One of the markers
of interest is adiponectin, a large 30-kDa protein produced mainly by adipocytes, sharing
strong homologies with TNF and the complement factor C1q. Plasma levels of adiponectin have
been negatively associated with indices of obesity, insulin resistance and cardiovascular
disease. However, its role in RA is still controversial with some evidence indicating a
proinflammatory effect and some other suggesting antiinflammatory properties of this
adipocytokine.
Aim of the present study was to evaluate the effect of different lifestyle intervention
administrations, in increasing adherence to the Mediterranean diet in a group of patients
with RA living in the Mediterranean basin, and, thus, in improving parameters related to
subjective and objective disease markers, including plasma adiponectin concentrations.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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