Effect of Glutathione on Blood Alcohol and Hangover Symptoms

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ClinicalTrials.gov Identifier: NCT00127309

Recruitment Status : Completed

First Posted : August 5, 2005

Last Update Posted : August 24, 2005

Sponsor:

Collaborator:

T.C Union Global Plc.

Information provided by:

Piyavate Hospital

Study Description

Brief Summary:

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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Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	June 2005
Study Completion Date :	August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
Males 20-40 years old
No allergies to alcohol

Exclusion Criteria:

Chronic disease
Increase in hepatic enzyme SGPT
Impending danger

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Thailand
Piyavate Hospital
Bangkok, Thailand, 10320

Sponsors and Collaborators

Piyavate Hospital

T.C Union Global Plc.

Investigators

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Principal Investigator:	Staporn Jinaratana, M.D	Piyavate Hospital

More Information

Publications:

L. Casciani et al.,Effect of GSH on hepatic triglyceride levels at different times after ethanol intoxification IRSC Med.Sci.,vol.14,158(1986)

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ClinicalTrials.gov Identifier:	NCT00127309
Other Study ID Numbers:	sj_1
First Posted:	August 5, 2005 Key Record Dates
Last Update Posted:	August 24, 2005
Last Verified:	July 2005

Keywords provided by Piyavate Hospital:


hangover hangover symptoms

Additional relevant MeSH terms:

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Alcohol Drinking Drinking Behavior

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