Postprandial FatiguePhase 1NCT01810549
Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study
A Phase 1 study testing Anakinra in people with Postprandial Fatigue, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Fatigue
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this 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.
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.
- Conditions
- Postprandial Fatigue
- Being tested
- Anakinra, Placebo
- Keywords
- Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.
PlaceboDrug
Also called Saline
Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Active comparator | Anakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection. Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Every study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial fatigue
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.
Measured: pre-study drug (180 minutes pre-meal), 30 minutes pre-meal and 30 minutes post-meal
Secondary outcomes (4)
Postprandial depression
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.
Measured: pre-study drug (180 minutes pre test meal), 30 minutes pre-meal, 30 minutes post-meal
Postprandial cognitive processing speed
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.
Measured: pre-study drug (180 minutes before test meal), 30 minutes pre-meal, 30 minutes post-meal
Insulin, C-peptide, Glucose
Measured: -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
Gut hormones and inflammatory markers
Measured: -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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial FatigueStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Y Donath, Prof., Principal investigator, Univesity Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810549
- Sponsor's protocol ID
- EK 303/12
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01810549
- Acronym / sponsor ID
- EK 303/12
- Conditions
- Postprandial Fatigue
- Keywords
- Fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Active comparator | Drug: AnakinraAnakinra 100mg. Every subject will receive one subcutaneous injection of study drug once during the study, a total of one injection. |
| Placebo | Placebo comparator | Drug: PlaceboEvery study participant will receive a single subcutaneous injection of Placebo once during the study, a total of one injection. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male
- non-smoking
- apparently healthy
- BMI >18 and ≤25 kg/m2
- Age 20-50 years
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraAlso: KineretEach subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection. | Drug | Anakinra |
| PlaceboAlso: SalineEvery subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection. | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Postprandial depression
Time frame: pre-study drug (180 minutes pre test meal), 30 minutes pre-meal, 30 minutes post-meal
Postprandial cognitive processing speed
Time frame: pre-study drug (180 minutes before test meal), 30 minutes pre-meal, 30 minutes post-meal
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Y Donath, Prof. principal investigator
Univesity Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anakinra in people with Postprandial Fatigue, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial fatigue (time frame: pre-study drug (180 minutes pre-meal), 30 minutes pre-meal and 30 minutes post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.