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

NCT01810549 | Completed Phase 1

• 1 other identifier: EK 303/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Fatigue

Keywords

Fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  pre-study drug (180 minutes pre-meal), 30 minutes pre-meal and 30 minutes post-meal

Secondary Outcomes (4)

• Postprandial depression

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

• Postprandial cognitive processing speed

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

• Insulin, C-peptide, Glucose

  -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

  -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

Study Arms (2)

Anakinra

ACTIVE COMPARATOR

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

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.

Drug: Placebo

Interventions

Anakinra DRUG

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

Also known as: Kineret

Anakinra

Placebo DRUG

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Fatigue

Interventions

Interleukin 1 Receptor Antagonist Protein; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Marc Y Donath, Prof.

  Univesity Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: December 17, 2014

Record last verified: 2013-03

Locations

CH (1)