Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study. A Randomized, Double-blind, Single Dose of Anakinra, Placebo-controlled, Cross-over Proof-of-concept Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postprandial fatigue
研究概览
简要总结
The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of a high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented by inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •non-smoking
- •apparently healthy
- •BMI >18 and ≤25 kg/m2
- •Age 20-50 years
- •Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
排除标准
- •Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
- •Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
- •Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
- •Kidney disease (creatinine > 1.5 mg/dL))
- •Liver disease (transaminases >2x upper normal range)
- •Heart disease
- •Pulmonary disease
- •Inflammatory disease
- •History of carcinoma
- •History of tuberculosis
- •Alcohol consumption >40g/d
- •Known allergy towards Anakinra
- •Known allergy towards ingredients of the test meal
- •Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
- •Use of any investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational drug, whichever is longer
- •Subject refusing or unable to give written informed consent
研究组 & 干预措施
Anakinra
Anakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection.
干预措施: Anakinra (Drug)
Placebo
Every study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Postprandial fatigue
时间窗: pre-study drug (180 minutes pre-meal), 30 minutes pre-meal and 30 minutes post-meal
Fatigue will be assessed using the Fatigue Scale for Motor and Cognitive Functions (FSMC) pre-study drug (means 180 minutes before ingestion of the test meal), 30 minutes before ingestion of the test meal and again 30 minutes after ingestion of the test meal. The outcome measure for which data will be presented is the change in fatigue measured 30 minutes before and 30 minutes after ingestion of the test meal in participants receiving kineret vs. placebo. Fatigue will also be assessed before administration of the study drug (180 minutes before test meal) to unravel a possible influence of the study drug itself on fatigue symptoms.
次要结局
- Gut hormones and inflammatory markers(-180, -10 and 0 minutes before ingestion of the test meal; 5, 15, 30, 60, 90, 120, 180 and 240 minutes after full ingestion of the test meal)
- Insulin, C-peptide, Glucose(-180, -10 and 0 minutes before ingestion of the test meal; 5, 15, 30, 60, 90, 120, 180 and 240 minutes after full ingestion of the test meal)
- Postprandial cognitive processing speed(pre-study drug (180 minutes before test meal), 30 minutes pre-meal, 30 minutes post-meal)
- Postprandial depression(pre-study drug (180 minutes pre test meal), 30 minutes pre-meal, 30 minutes post-meal)