Effect of Glutathione on Blood Alcohol and Hangover Symptoms

Study Overview
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Brief Summary
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Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant. As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and excretes in urine as mercapturic acid. In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect. The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. This study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the Slutske et al study.

Detailed Description
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Type of Study: Double-blinded control Population: 100 males Inclusion Criteria: Males 20-40 years Healthy, without chronic diseases, especially must have normal hepatic function, measured by serum SGPT No history of alcoholic allergy Drink alcohol regularly, at least once a week Agree to be a subject by standard consent form Exclusion Criteria: Subject wants to end the study Some impending danger to subjects Number of subjects : 100 Methodology Subjects are recruited; History taking, physical examination and SGPT are done by M.D.; 100 subjects are distributed randomly to numbers 1-100; Factory provides 2 groups of capsules in randomized packets numbered 1 -100; each package contains 3 sub-packages; each sub-package contains 2 capsules of either placebo or 370 mg glutathione capsules. All the three sub-packages will be all placebo or all glutathione. 50 packages are placebo and 50 packages are glutathione; Subjects are examined as follows: Hour 0: 3 ml of blood taken for blood alcohol and blood acetaldehyde; Hour 0- 1: consume Thai Whisky (40% alcohol) 60 ml with snacks; Hour 1: ml of blood taken for blood alcohol and blood acetaldehyde; Hour 1.30: ml of blood taken for blood alcohol and blood acetaldehyde; Hour 2.30: ml of blood taken for blood alcohol and blood acetaldehyde; Hour 3.30: ml of blood taken for blood alcohol and blood acetaldehyde; Hour 12: ml of blood taken for blood alcohol and blood acetaldehyde, and Alcohol Hangover Symptom evaluation of each subject is done individually. Using Wendy S. Slutske et al Scale 0-4: 0= no symptom minimal some much most Symptoms are extreme thirst or dehydration more tired than usual headache nausea vomiting very weak difficulty concentrating more sensitive to light and sound than usual more sweating than usual have a lot of trouble sleeping anxious depressed trembling or shaking Blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for significance.

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: Glutathione


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Males 20-40 years old No allergies to alcohol Exclusion Criteria: Chronic disease Increase in hepatic enzyme SGPT Impending danger

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glutathione|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hangover, hangover symptoms