Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Study Overview
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Brief Summary
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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.

Official Title
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Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia

Conditions
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Human Endotoxaemia

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men Age 18-49 year. Healthy No sleepiness disorders. No medication ASA I Exclusion Criteria: Allergia to melatonin Women Smoking. Alcohol abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LPS + melatonin night<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|
| Placebo Comparator: LPS + placebo night<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|
| Active Comparator: LPS + melatonin day<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|
| Placebo Comparator: LPS + placebo day<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|
| Experimental: LPS night<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|
| Experimental: LPS day<br> | Drug: Melatonin<br>* 100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatoric markers | IL-6 TNF-alpha YKL-40 | measured before and after the administration of LPS endotoxin. | 
| Oxidative markers | Vit C MDA (malondialdehyde) | measured before and after the administration of LPS endotoxin. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome | Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature | constant measurment |