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临床试验/NCT02028624
NCT02028624已完成不适用

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

Harokopio University4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
4
主要终点
Change from baseline plasma glucose levels at 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Minimum Intervention

No Intervention

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

Face-to-face

Experimental

Patients received face-to-face nutrition counseling.

干预措施: Nutrition counseling (Behavioral)

Telephone

Experimental

Patients received telephone nutrition counseling.

干预措施: Nutrition counseling (Behavioral)

结局指标

主要结局

Change from baseline plasma glucose levels at 6 months

时间窗: 6 months

Change from baseline serum triglycerides levels at 6 months

时间窗: 6 months

Change from baseline plasma HDL-cholesterol levels at 6 months

时间窗: 6 months

Change from baseline body weight at 6 months

时间窗: 6 months

Change from baseline Mediterranean Diet Score at 6 months

时间窗: 6 months

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

时间窗: 6 months

Change from baseline energy intake at 6 months

时间窗: 6 months

Change from baseline plasma adiponectin concentrations at 6 months

时间窗: 6 months

Years of education

时间窗: baseline

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

时间窗: 6 months

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

时间窗: 6 months

Height

时间窗: baseline

Change from baseline in macronutrients intake at 6 months

时间窗: 6 months

Change from baseline systolic blood pressure at 6 months

时间窗: 6 months

Change from baseline diastolic blood pressure at 6 months

时间窗: 6 months

Age

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Yannakoulia

Dr Mary Yannakoulia

Harokopio University

研究点 (4)

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