Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127309
Status:
COMPLETED
Last Update Posted:
2005-08-24
First Post:
2005-08-04
Brief Title:
Effect of Glutathione on Blood Alcohol and Hangover Symptoms
Sponsor:
Piyavate Hospital
Organization:
Piyavate Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
1 Subjects are recruited
2 History taking physical examination and SGPT are done by MD
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 130 ml of blood taken for blood alcohol and blood acetaldehyde
Hour 230 ml of blood taken for blood alcohol and blood acetaldehyde
Hour 330 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
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 MD
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 130 ml of blood taken for blood alcohol and blood acetaldehyde
Hour 230 ml of blood taken for blood alcohol and blood acetaldehyde
Hour 330 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None