Effect of Glutathione on Blood Alcohol and Hangover Symptoms

This study has been completed.
Sponsor:
Collaborator:
T.C Union Global Plc.
Information provided by:
Piyavate Hospital
ClinicalTrials.gov Identifier:
NCT00127309
First received: August 4, 2005
Last updated: August 23, 2005
Last verified: July 2005

August 4, 2005
August 23, 2005
June 2005
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Complete list of historical versions of study NCT00127309 on ClinicalTrials.gov Archive Site
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Effect of Glutathione on Blood Alcohol and Hangover Symptoms
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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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alcohol Drinking
Drug: Glutathione
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L. Casciani et al.,Effect of GSH on hepatic triglyceride levels at different times after ethanol intoxification IRSC Med.Sci.,vol.14,158(1986)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2005
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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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00127309
sj_1
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Piyavate Hospital
T.C Union Global Plc.
Principal Investigator: Staporn Jinaratana, M.D Piyavate Hospital
Piyavate Hospital
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP