Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Nutrition counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Mediterranean diet, Lifestyle intervention, Adiponectin, Telephone counseling
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
Sites / Locations
- Euroclinic Private Hopsital
- Laiko General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Face-to-face
Telephone
Minimum Intervention
Arm Description
Patients received face-to-face nutrition counseling.
Patients received telephone nutrition counseling.
Patients in this group received no further lifestyle-related counseling and contact until the 6-month evaluation.
Outcomes
Primary Outcome Measures
Change from baseline Mediterranean Diet Score at 6 months
Change from baseline Disease Activity Score (DAS28) at 6 months
Change from baseline Health Assessment Questionnaire (HAQ) Score at 6 months
Change from baseline Short Form-36 Health Survey (SF-36) score at 6 months
Change from baseline energy intake at 6 months
Change from baseline in macronutrients intake at 6 months
Age
Height
Change from baseline body weight at 6 months
Change from baseline systolic blood pressure at 6 months
Change from baseline plasma adiponectin concentrations at 6 months
Change from baseline plasma glucose levels at 6 months
Change from baseline serum triglycerides levels at 6 months
Change from baseline plasma HDL-cholesterol levels at 6 months
Years of education
Change from baseline diastolic blood pressure at 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT02028624
First Posted
January 1, 2014
Last Updated
January 4, 2014
Sponsor
Harokopio University
Collaborators
State Scholarships Foundation, Athens, Greece
1. Study Identification
Unique Protocol Identification Number
NCT02028624
Brief Title
Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis
Official Title
Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
State Scholarships Foundation, Athens, Greece
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Mediterranean diet, Lifestyle intervention, Adiponectin, Telephone counseling
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-to-face
Arm Type
Experimental
Arm Description
Patients received face-to-face nutrition counseling.
Arm Title
Telephone
Arm Type
Experimental
Arm Description
Patients received telephone nutrition counseling.
Arm Title
Minimum Intervention
Arm Type
No Intervention
Arm Description
Patients in this group received no further lifestyle-related counseling and contact until the 6-month evaluation.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition counseling
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Mediterranean Diet Score at 6 months
Time Frame
6 months
Title
Change from baseline Disease Activity Score (DAS28) at 6 months
Time Frame
6 months
Title
Change from baseline Health Assessment Questionnaire (HAQ) Score at 6 months
Time Frame
6 months
Title
Change from baseline Short Form-36 Health Survey (SF-36) score at 6 months
Time Frame
6 months
Title
Change from baseline energy intake at 6 months
Time Frame
6 months
Title
Change from baseline in macronutrients intake at 6 months
Time Frame
6 months
Title
Age
Time Frame
baseline
Title
Height
Time Frame
baseline
Title
Change from baseline body weight at 6 months
Time Frame
6 months
Title
Change from baseline systolic blood pressure at 6 months
Time Frame
6 months
Title
Change from baseline plasma adiponectin concentrations at 6 months
Time Frame
6 months
Title
Change from baseline plasma glucose levels at 6 months
Time Frame
6 months
Title
Change from baseline serum triglycerides levels at 6 months
Time Frame
6 months
Title
Change from baseline plasma HDL-cholesterol levels at 6 months
Time Frame
6 months
Title
Years of education
Time Frame
baseline
Title
Change from baseline diastolic blood pressure at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Yannakoulia, PhD
Organizational Affiliation
Harokopio University
Official's Role
Study Director
Facility Information:
Facility Name
Euroclinic Private Hopsital
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Laiko General Hospital
City
Athens
ZIP/Postal Code
15773
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Interventions Based on the Mediterranean Diet for Patients With Rheumatoid Arthritis
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