Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study
NCT ID: NCT01810549
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anakinra
Anakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection.
Anakinra
Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.
Placebo
Every study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection.
Placebo
Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anakinra
Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.
Placebo
Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Y Donath, Prof.
Role: PRINCIPAL_INVESTIGATOR
Univesity Hospital Basel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Basel
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EK 303/12
Identifier Type: -
Identifier Source: org_study_id