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NCT Number: NCT02028624

Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Euroclinic Private Hopsital, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults
  • rheumatoid arthritis diagnosis according to the 1987 criteria of the American College of Rheumatology
  • clinically non active disease, as assessed and documented by the patient's own rheumatology specialist

Exclusion criteria

  • being on a slimming or any other special diet during the previous year, or being diagnosed with other serious medical conditions

Treatment and study plan

Nutrition counseling

Behavioral

Patients received nutrition counseling, through one-to-one sessions conducted once a month, until the 6-month evaluation. Nutrition counseling was based on goal-setting and aimed at increasing adherence to Mediterannean diet.

Primary outcomes

  1. Change from baseline Mediterranean Diet Score at 6 months

    Time frame: 6 months

  2. Change from baseline Disease Activity Score (DAS28) at 6 months

    Time frame: 6 months

  3. Change from baseline Health Assessment Questionnaire (HAQ) Score at 6 months

    Time frame: 6 months

  4. Change from baseline Short Form-36 Health Survey (SF-36) score at 6 months

    Time frame: 6 months

  5. Change from baseline energy intake at 6 months

    Time frame: 6 months

  6. Change from baseline in macronutrients intake at 6 months

    Time frame: 6 months

  7. Age

    Time frame: baseline

  8. Height

    Time frame: baseline

  9. Change from baseline body weight at 6 months

    Time frame: 6 months

  10. Change from baseline systolic blood pressure at 6 months

    Time frame: 6 months

  11. Change from baseline plasma adiponectin concentrations at 6 months

    Time frame: 6 months

  12. Change from baseline plasma glucose levels at 6 months

    Time frame: 6 months

  13. Change from baseline serum triglycerides levels at 6 months

    Time frame: 6 months

  14. Change from baseline plasma HDL-cholesterol levels at 6 months

    Time frame: 6 months

  15. Years of education

    Time frame: baseline

  16. Change from baseline diastolic blood pressure at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • State Scholarships Foundation, Athens, Greece

Registry information

Official study title

Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis: a Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2014
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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