Alcohol Drinking Clinical Trial
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.
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
1. Subjects are recruited;
2. History taking, physical examination and SGPT are done by M.D.;
3. 100 subjects are distributed randomly to numbers 1-100;
4. 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;
5. 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
1. minimal
2. some
3. much
4. most
Symptoms are
1. extreme thirst or dehydration
2. more tired than usual
3. headache
4. nausea
5. vomiting
6. very weak
7. difficulty concentrating
8. more sensitive to light and sound than usual
9. more sweating than usual
10. have a lot of trouble sleeping
11. anxious
12. depressed
13. trembling or shaking
Blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for
significance.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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