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

Early Phase 1

• Conditions: G6PD Deficiency
• Interventions: Drug: N-acetyl cystein; Other: Placebo

• Registration Number: NCT02937376
• Lead Sponsor: University of Thessaly

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 Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-05
• Study Start: 2023-02-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
N-acetyl Cystein	N-acetyl cystein	NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Placebo	Placebo	Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

Primary Outcome Measures

Name	Time	Method
Change in redox status after exercise	Before, immediately after and 1 hour after each trial of exercise	Indices of blood redox status

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo	Blood pressure at rest
Body composition	Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo	Body fat percentage

Trial Locations

Locations (1)

Department of Physical Education & Sport Science of the University of Thessaly; 🇬🇷 Trikala, Karyes, Greece