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Clinical Trials/NCT02937376
NCT02937376
Unknown
Early Phase 1

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

University of Thessaly1 site in 1 country12 target enrollmentFebruary 1, 2023

Overview

Phase
Early Phase 1
Intervention
N-acetyl cystein
Conditions
G6PD Deficiency
Sponsor
University of Thessaly
Enrollment
12
Locations
1
Primary Endpoint
Change in redox status after exercise
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
November 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Athanasios Z. Jamurtas

Professor

University of Thessaly

Eligibility Criteria

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

Placebo

Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

Intervention: Placebo

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)

Study Sites (1)

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