Evaluation of the Effect of the Mediterranean Diet on Disease Activity and Treatment Response in Patients With Axial Spondyloarthritis Receiving Biologic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein)
研究概览
简要总结
This study aims to evaluate the effect of the Mediterranean diet on disease activity, quality of life, inflammation, pain, and treatment response in patients with axial spondyloarthritis (ankylosing spondylitis) who are receiving stable biologic therapy. Axial spondyloarthritis is a chronic inflammatory disease that affects the spine and sacroiliac joints, often leading to pain, stiffness, and reduced quality of life. While biologic disease-modifying antirheumatic drugs (bDMARDs) are effective in reducing inflammation, lifestyle factors such as diet may also play an important role in disease outcomes.
In this randomized controlled trial, a total of 110 patients diagnosed with ankylosing spondylitis will be enrolled. Participants will be randomly assigned to either the Mediterranean diet group or the control group. The Mediterranean diet group will receive a structured diet program supervised by a dietitian, while the control group will continue their standard care with general healthy eating advice. Patients will be monitored for dietary adherence, and assessments will be conducted at baseline and after 3 months.
The primary outcome measure is the change in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP). Secondary outcomes include BASDAI, BASFI, BASMI, laboratory markers of inflammation, quality of life (SF-36), fatigue (FACIT-Fatigue), sleep quality (PSQI), anxiety and depression (HADS), medication adherence (MMAS-8), and Mediterranean diet adherence (PREDIMED). The study will provide valuable data on whether a Mediterranean diet can improve clinical outcomes and support the management of axial spondyloarthritis in patients receiving biologic therapy, potentially contributing to future lifestyle-based treatment strategies.
详细描述
Aim This study is designed to investigate the effects of the Mediterranean diet on disease activity, quality of life, inflammation levels, pain scores, and the frequency of biologic DMARD use in patients with ankylosing spondylitis (AS) receiving biologic disease-modifying antirheumatic drugs (bDMARDs).
Background Ankylosing spondylitis (AS) is a chronic inflammatory disease that causes early inflammation in the sacroiliac joints and, in later stages, also affects the axial skeleton. Structural and functional impairment, together with inflammatory back pain, lead to a marked reduction in quality of life. Genetic factors, intestinal microbiota, mechanical stress on the spine and peripheral joints, innate immunity, oxidative stress, lifestyle, and environmental influences are thought to play important roles in the pathogenesis of AS.
Both pharmacological and non-pharmacological strategies are used in the treatment of AS. The primary goal of treatment is to control symptoms and inflammation, prevent structural damage, and maximize long-term quality of life. However, there is limited evidence supporting the effectiveness of lifestyle modifications. Among environmental factors, diet is a modifiable component with the potential to reduce inflammation. Certain foods may trigger inflammatory processes, whereas nutrients such as antioxidants and omega-3 fatty acids may exert anti-inflammatory effects.
The Mediterranean diet (MD), with its anti-inflammatory and antioxidant potential, is considered a promising dietary model in chronic inflammatory conditions. This dietary pattern emphasizes high consumption of olive oil, unrefined carbohydrates, fresh and dried fruits, vegetables, and fish; low consumption of dairy products and red meat; and moderate consumption of red wine. In AS, such nutrients may reduce inflammation, alleviate pain, decrease structural damage, and potentially improve quality of life. No study has specifically compared the Mediterranean diet in AS patients receiving stable bDMARD therapy with a control group. This trial is intended to address this gap.
Hypothesis The investigators hypothesize that the Mediterranean diet will reduce disease activity, improve quality of life, and lower inflammation in patients with AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study. The outcomes assessor will be blinded to group allocation. Participants and care providers will be aware of the assigned intervention due to the nature of dietary modification.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosis of ankylosing spondylitis according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria.
- •No dietary changes within the past 3 months.
- •Stable treatment with NSAIDs or DMARDs for at least the previous 4 months.
- •Receiving biologic therapy (bDMARDs) with no changes in medication for the last 4 months.
- •Willingness and ability to provide written informed consent
排除标准
- •Pregnancy or breastfeeding.
- •Nutritional restrictions preventing adherence to the Mediterranean diet (e.g., severe food allergies).
- •Participation in another diet- or exercise-based intervention program within the last 6 months.
- •Presence of another rheumatologic disease or history of neurological disorders.
- •Individuals younger than 18 years.
- •Contraindications to body composition analysis (e.g., cardiac pacemaker, pregnancy).
研究组 & 干预措施
Mediterranean Diet Group
Participants will follow a structured Mediterranean diet program designed and supervised by a dietitian. Adherence will be reinforced through follow-up phone calls every 10 days. Assessments will be performed at baseline and after 3 months.
干预措施: Mediterranean Diet (Behavioral)
Control Group (Standard Care)
Participants will continue their standard medical treatment and will receive general healthy eating advice in addition to routine care. Assessments will be performed at baseline and after 3 months
干预措施: Healthy Eating Advice (Behavioral)
结局指标
主要结局
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein)
时间窗: Baseline and 3 months
ASDAS-CRP is a validated composite index for disease activity in ankylosing spondylitis. Disease activity states are classified as inactive (\<1.3), low (\<2.1), high (\<3.5), and very high (\>3.5). The primary outcome is the change in ASDAS-CRP score from baseline to 3 months.
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline and 3 months)
- th Ankylosing Spondylitis Functional Index (BASFI)(Baseline and 3 months)
- Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline and 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and 3 months)
- Quality of Life (Short Form-36, SF-36)(Baseline and 3 months)
- Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)(Baseline and 3 months)
- Medication Adherence (Morisky Medication Adherence Scale, MMAS-8)(Baseline and 3 months)
- Mediterranean Diet Adherence (PREDIMED Score)(Baseline and 3 months)
- Hand Grip Strength(Baseline and 3 months)
- Body Composition (InBody 270 Bioelectrical Impedance Analysis)(Baseline and 3 months)
研究者
Sinem Kübra Beke
Associate Professor
TC Erciyes University