Skip to main content
OpenTrials
Completed

NCT Number: NCT01810549

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.

Other names: Kineret

Placebo

Drug

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

Other names: Saline

Primary outcomes

  1. Postprandial fatigue

    Time frame: 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.

Secondary outcomes

  1. Postprandial depression

    Time frame: pre-study drug (180 minutes pre test meal), 30 minutes pre-meal, 30 minutes post-meal

    Depression will be assessed using the Hospitality Anxiety and Depression Scale - german version (HADS-D) 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 depression measured 30 minutes before and 30 minutes after ingestion of the test meal in participants receiving kineret vs. placebo. Depression 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 depression.

  2. Postprandial cognitive processing speed

    Time frame: pre-study drug (180 minutes before test meal), 30 minutes pre-meal, 30 minutes post-meal

    Cognitive processing speed will be assessed using the oral version of the Symbol Digit Modalities Test (SDMT) version A before study drug (means 180 minutes before ingestion of the test meal), version B 30 minutes before ingestion of the test meal and version A 30 minutes after ingestion of the test meal. The outcome measure for which data will be presented is the change in cognitive processing speed measured 30 minutes before and 30 minutes after ingestion of the test meal in participants receiving kineret vs. placebo. Cognitive processing speed 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 depression. Version A and B will be used alternately to prevent a learning effect in this test.

  3. Insulin, C-peptide, Glucose

    Time frame: -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

  4. Gut hormones and inflammatory markers

    Time frame: -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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
First posted
Mar 13, 2013
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.