Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adherence - Fermented Food Diet
研究概览
简要总结
This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).
详细描述
Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Able to provide informed consent and undertake study questionnaire completion in English
- •Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
- •Be willing and able to comply with all the study-related procedures
排除标准
- •Pregnant or planning pregnancy within the duration of the interventional study.
- •Currently following a vegetarian/vegan diet.
- •Allergy/sensitivity to gluten, soy, or cow's milk.
- •Self-disclosure of lactose intolerance
- •Inability to comply with the study procedures.
- •Baseline dietary fiber intake > 30 g/day
- •MEDAS score at baseline > 9
- •Baseline consumption of > 2 servings per day of fermented foods
结局指标
主要结局
Adherence - Fermented Food Diet
时间窗: baseline, month 1, 2, and 3
Percent of participants achieving \> 5 servings of fermented foods per day
Adherence - Mediterranean Diet
时间窗: baseline, month 1, 2 and 3
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
次要结局
- Systemic Lupus Erythematosus Disease Activity(baseline, month 3)
- ESR(baseline, month 3)
- Diet Quality(baseline, month 3)
- hsCRP(baseline, month 3)
- anti-dsDNA(baseline, month 3)
- Cytokine profile(baseline, month 3)