Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- University of Thessaly
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in redox status after exercise
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
N-acetyl Cystein
NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Intervention: N-acetyl cystein (Drug)
Placebo
Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in redox status after exercise
Time Frame: Before, immediately after and 1 hour after each trial of exercise
Indices of blood redox status
Secondary Outcomes
- Body composition(Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo)
- Blood pressure(Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo)
Investigators
Athanasios Z. Jamurtas
Professor
University of Thessaly