NCT05799768Enrolling By Invitation不适用
Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- hsCRP
研究概览
简要总结
This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
- •On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)
排除标准
- •Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
- •Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
- •Insulin use
- •Hospitalization in the 30 days prior to study enrollment
- •Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
- •Malignancy
- •Chronic infection (HIV, hep B/C, etc.)
- •Heavy drinking
- •On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
- •Recent weight loss (>5% in the last 2 months)
结局指标
主要结局
hsCRP
时间窗: 6 weeks
Systemic marker of inflammation
次要结局
- DAS28-CRP(6 weeks)
研究者
研究点 (2)
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