Rheumatoid Arthritis Clinical Trial
Official title:
Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis: a Randomized Controlled Trial
Verified date | January 2014 |
Source | Harokopio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Greece | Euroclinic Private Hopsital | Athens | |
Greece | Laiko General Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Harokopio University | State Scholarships Foundation, Athens, Greece |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Mediterranean Diet Score at 6 months | 6 months | No | |
Primary | Change from baseline Disease Activity Score (DAS28) at 6 months | 6 months | No | |
Primary | Change from baseline Health Assessment Questionnaire (HAQ) Score at 6 months | 6 months | No | |
Primary | Change from baseline Short Form-36 Health Survey (SF-36) score at 6 months | 6 months | No | |
Primary | Change from baseline energy intake at 6 months | 6 months | No | |
Primary | Change from baseline in macronutrients intake at 6 months | 6 months | No | |
Primary | Age | baseline | No | |
Primary | Height | baseline | No | |
Primary | Change from baseline body weight at 6 months | 6 months | No | |
Primary | Change from baseline systolic blood pressure at 6 months | 6 months | No | |
Primary | Change from baseline plasma adiponectin concentrations at 6 months | 6 months | No | |
Primary | Change from baseline plasma glucose levels at 6 months | 6 months | No | |
Primary | Change from baseline serum triglycerides levels at 6 months | 6 months | No | |
Primary | Change from baseline plasma HDL-cholesterol levels at 6 months | 6 months | No | |
Primary | Years of education | baseline | No | |
Primary | Change from baseline diastolic blood pressure at 6 months | 6 months | No |
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