Postprandial Inflammation in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Urine metabolomics
研究概览
简要总结
Patients with RA will be studied to see whether meals of different content will affect inflammation and metabolic variables in the postprandial state. Healthy controls will also be invited to examine potentially different responses to patients with RA.
详细描述
The PIRA study aims to evaluate the metabolic and inflammatory effects after a vegan meal or a meal containing red meat or fish in patients with RA and matched controls. The study have a cross-over design and each participant will have one of three meals every week and then be compared to themselves. In addition healthy individuals will be included for the red meat meal so that the response from this meal could be compared between patients with RA and their matched controls. Blood samples will be collected before the meal (fasting) and every hour until 5h. Primary outcome will be high sensitive IL-6. Secondary outcomes will be additional inflammation markers such as area under curve for hs-CRP and gene expression in PBMC:s regarding genes related to inflammation and, glucose, blood lipids and metabolomics-profile in serum and urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for patients with RA:
- •Diagnosed with rheumatoid arthritis
- •BMI 18.5-30.0 kg/m2
- •2 years or more since diagnosis
- •No DMARD changes during the last 3 months
- •Inclusion Criteria for healthy controls:
- •Absence of diagnosis of RA
- •BMI 18.5-30.0 kg/m2
- •Self-assessed as healthy
排除标准
- •Diagnosis of cancer, inflammatory bowel disease, celiac disease, diabetes
- •Allergy or intolerance to any of the foods in the study
- •Pregnancy or breastfeeding
- •Use of any blood lipid lowering medication, glucocorticoids or IL-6-inhibitor during the last 4 weeks prior to enrolment
- •Hemoglobin < 100 g/L
结局指标
主要结局
Urine metabolomics
时间窗: From baseline up to 5 hours postprandial
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately
Serum metabolomics
时间窗: From baseline up to 5 hours postprandial
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Circulating interleukin 6
时间窗: From baseline up to 5 hours postprandial
Changes from fasting to postprandial
Circulating high sensitive C-reactive protein (CRP)
时间窗: From baseline up to 5 hours postprandial
Changes from fasting to 5 hours postprandial, area under curve
Gene expression analysis
时间窗: From baseline up to 5 hours postprandial
Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Circulating triacylglycerides
时间窗: From baseline up to 5 hours postprandial
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
次要结局
- Patient-reported quality of life(through study completion, expected to be complete within 1 year)
- Resting metabolic rate(through study completion, expected within 1 year)
- Insulin(From baseline up to 5 hours postprandial)
- Patient-reported health(through study completion, expected to be complete within 1 year)
- Patient-reported background and dietary habits(During trial, expected to be complete within 1 year)
- Glucose(From baseline up to 5 hours postprandial)
- Body composition(Measured at inclusion and during trial, expected to be complete within 1 year)
- Patient-reported dietary intake(Through study completion, expected to be complete within 1 year)
- Patient-reported disability(During trial, expected to be complete within 1 year)