Trial | NCT00127309  Report issue

Title

Effect of Glutathione on Blood Alcohol and Hangover Symptoms

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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

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.
Study Started
Jun 30
2005
Study Completion
Aug 31
2005
Last Update
Aug 24
2005
Estimate

Drug Glutathione

Criteria 

Inclusion Criteria:

Healthy
Males 20-40 years old
No allergies to alcohol

Exclusion Criteria:

Chronic disease
Increase in hepatic enzyme SGPT
Impending danger
No Results Posted