Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study

University of Zurich (UZH)

Status and phase: Completed; Phase 1

Conditions: Postprandial Fatigue

Treatments: Drug: Placebo; Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT01810549

EK 303/12

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups, including a placebo group

Anakinra

Active Comparator group

Description:

Anakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection.

Treatment:

Drug: Anakinra

Placebo

Placebo Comparator group

Description:

Every study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection.

Treatment:

Drug: Placebo