Human Endotoxaemia
Conditions
Brief summary
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days: * day 1: On day time administration of LPS. * day 2: On night time administration of LPS. * day 3: On day time administration of LPS + Placebo. * day 4: On day time administration of LPS + melatonin. * day 5: On night time administration of LPS + placebo. * day 6: On night time administration og LPS + melatonin. Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
Interventions
DRUGMelatonin
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Men * Age 18-49 year. * Healthy * No sleepiness disorders. * No medication * ASA I
Exclusion criteria
* Allergia to melatonin * Women * Smoking. * Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatoric markers | measured before and after the administration of LPS endotoxin. | IL-6 TNF-alpha YKL-40 |
| Oxidative markers | measured before and after the administration of LPS endotoxin. | Vit C MDA (malondialdehyde) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | constant measurment | Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature |
Countries
Denmark
Outcome results
None listed