Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of N-acetyl Cystein (NAC) supplementation on redox status, physiological and biochemical parameters in G6PD deficient individuals after acute exercise.

Detailed Description
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In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of both sexes will be supplemented with either 10 mg/kg of NAC (experimental condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2max test will be performed. Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion) before and after each condition. Blood samples will be collected before, immediately after and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and physiological parameters will be performed before and after each condition. There will be a washout period of at 4 weeks between conditions.

Official Title
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Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise

Conditions
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G6PD Deficiency

Intervention / Treatment
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* Drug: N-acetyl cystein
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: G6PD deficiency Exclusion Criteria: Any uncontrolled health condition for which exercise is contraindicated Current use of dietary supplements or drugs Pregnant, pregnancy intention or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetyl Cystein<br>NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. | Drug: N-acetyl cystein<br>* A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.<br>* Other names: Trebon;|
| Placebo Comparator: Placebo<br>Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. | Other: Placebo<br>* A trial of exercise before and after 4 weeks of placebo administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in redox status after exercise | Indices of blood redox status | Before, immediately after and 1 hour after each trial of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body fat percentage | Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo | 
| Blood pressure | Blood pressure at rest | Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo |