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

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ClinicalTrials.gov Identifier: NCT01810549
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Postprandial Fatigue Drug: Anakinra Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 Start Date : March 2013
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Anakinra

Arm Intervention/treatment
Active Comparator: Anakinra
Anakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection.
Drug: Anakinra
Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.
Other Name: Kineret

Placebo Comparator: Placebo
Every study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection.
Drug: Placebo
Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
Other Name: Saline




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810549


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Marc Y Donath, Prof. Univesity Hospital Basel

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01810549    
Other Study ID Numbers: EK 303/12
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: March 2013
Keywords provided by University of Zurich:
Fatigue
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents