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

NCT ID: NCT02028624

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Face-to-face

Patients received face-to-face nutrition counseling.

Group Type: EXPERIMENTAL

Nutrition counseling

Intervention Type: 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.

Telephone

Patients received telephone nutrition counseling.

Group Type: EXPERIMENTAL

Nutrition counseling

Intervention Type: 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.

Minimum Intervention

Patients in this group received no further lifestyle-related counseling and contact until the 6-month evaluation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrition counseling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Scholarships Foundation, Athens, Greece

UNKNOWN

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

M. Yannakoulia

Dr Mary Yannakoulia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Yannakoulia, PhD

Role: STUDY_DIRECTOR

Harokopio University

Locations

Euroclinic Private Hopsital

Athens, , Greece

Laiko General Hospital

Athens, , Greece

Countries

Greece

Other Identifiers

RASt

Identifier Type: -

Identifier Source: org_study_id