Clinical trial NCT01810549: Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postprandial Fatigue
Keywords: Fatigue
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* male
* 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.

Exclusion Criteria:

* 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
* Smoking
* 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

Primary outcomes:
measure: Postprandial fatigue
timeFrame: pre-study drug (180 minutes pre-meal), 30 minutes pre-meal and 30 minutes post-meal
Secondary outcomes:
measure: Postprandial depression
timeFrame: pre-study drug (180 minutes pre test meal), 30 minutes pre-meal, 30 minutes post-meal
measure: Postprandial cognitive processing speed
timeFrame: pre-study drug (180 minutes before test meal), 30 minutes pre-meal, 30 minutes post-meal
measure: Insulin, C-peptide, Glucose
timeFrame: -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
measure: Gut hormones and inflammatory markers
timeFrame: -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
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Univesity Hospital Basel
name: Marc Y Donath, Prof.
role: PRINCIPAL_INVESTIGATOR
References: