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CompletedNCT02028624Updated Jan 7, 2014

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

An interventional study of Nutrition counseling in Rheumatoid Arthritis, sponsored by Harokopio University. Completed at 2 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-07.

Sponsored by Harokopio University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis
  • Mediterranean diet
  • Lifestyle intervention
  • Adiponectin
  • Telephone counseling
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 48 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Harokopio University is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • being on a slimming or any other special diet during the previous year, or being diagnosed with other serious medical conditions
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Face-to-face

    Patients received face-to-face nutrition counseling.

    Behavioral: Nutrition counseling

  • Experimental
    Telephone

    Patients received telephone nutrition counseling.

    Behavioral: Nutrition counseling

  • No intervention
    Minimum Intervention

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

Interventions

  • BehavioralNutrition 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.

06

What researchers measure

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

07

Study locations

2 sites
  • Euroclinic Private Hopsital
    Athens, 11521, Greece
  • Laiko General Hospital
    Athens, 15773, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02028624
Lead sponsor
Harokopio University
Collaborators
State Scholarships Foundation, Athens, Greece
Responsible party
M. Yannakoulia (Dr Mary Yannakoulia, Harokopio University) — Principal investigator
First posted
Jan 7, 2014
Start date
Sep 2009
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Jan 7, 2014

Study contacts

Mary Yannakoulia, PhD
study director · Harokopio University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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