Effect of Glutathione on Blood Alcohol and Hangover Symptoms
|ClinicalTrials.gov Identifier: NCT00127309|
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : August 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking||Drug: Glutathione||Not Applicable|
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Type of Study: Double-blinded control
Population: 100 males
- 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
- Subject wants to end the study
- Some impending danger to subjects
Number of subjects : 100
- 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
- extreme thirst or dehydration
- more tired than usual
- very weak
- difficulty concentrating
- more sensitive to light and sound than usual
- more sweating than usual
- have a lot of trouble sleeping
- trembling or shaking
Blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for significance.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||June 2005|
|Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127309
|Bangkok, Thailand, 10320|
|Principal Investigator:||Staporn Jinaratana, M.D||Piyavate Hospital|