Exploring the Mediterranean Diet as A Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Serum and Fecal Short Chain Fatty Acids
研究概览
简要总结
The goal of this study is to compare pain levels in individuals with Sickle Cell Disease while following the Mediterranean Diet to pain levels while following their usual diet.
详细描述
This is an exploratory, randomized, crossover-controlled feeding study of a 4-week Mediterranean Diet or usual diet control among 24 adults with sickle cell disease and chronic pain (30 will be recruited, with an estimated 24 participants completing the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Sickle Cell Disease Diagnosis
- •Chronic non-vaso-occlusive pain experienced on average ≥ 3 days per week for > 6 months (based on a response of "Most days," "Every day," or "Some days" and not "Never" to the question "In the past 6 months, how often have you had pain?")
- •Ability to speak, read, write, and understand English
- •A Mediterranean Eating Pattern for Americans (MEPA-III) score <13, indicating that they do not follow a Mediterranean diet.
排除标准
- •Having taken systemic antimicrobials (to treat an infection in the previous 4 weeks)
- •History of colon cancer or inflammatory bowel disease (given potential untoward effects on the gut microbiome)
- •History of Clostridium difficile infection in the preceding 12 weeks;
- •Unable to agree to maintain physical activity at the current level for the duration of the study
- •Currently following a Mediterranean diet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a Mediterranean diet
- •Lack of access to a space to safely store and reheat food items
- •Living in a facility that provides meals.
- •Pregnancy or breastfeeding
- •More than 7 in-patient hospital stays in the last year
- •Currently receiving dialysis treatment
研究组 & 干预措施
Mediterranean Diet
Commercially prepared foods will be provided.
干预措施: Mediterranean Diet (Other)
Mediterranean Diet
Commercially prepared foods will be provided.
干预措施: Usual Diet (Other)
Usual Diet
Consume their typical at-home diet.
干预措施: Mediterranean Diet (Other)
Usual Diet
Consume their typical at-home diet.
干预措施: Usual Diet (Other)
结局指标
主要结局
Serum and Fecal Short Chain Fatty Acids
时间窗: Baseline and day 27 or 28 of each diet
Mass spectrometry methods for butyrate, propionate, acetate
Serum and Fecal Bile Acid Metabolites
时间窗: Baseline and day 27 or 28 of each diet
Mass spectrometry methods for primary and secondary bile acid derivatives
次要结局
- Gut Microbiota Composition(Baseline and day 27 or 28 of each diet)
- Chronic Pain(Baseline and day 27 or 28 of each diet)
- Diet adherence(Baseline and day 27 or 28 of each diet)
- Diet adherence(Daily up to 4 weeks during the Mediterranean diet intervention)