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

G6PD Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02937376
• Other study ID #: UTH_G6PD 2
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2022
• Source: University of Thessaly
• Contact: Athanasios Z Jamurtas, PhD
• Phone: +30-2431047054
• Email: ajamurt[@]pe.uth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency

Intervention

Drug:
• N-acetyl cystein
A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.

Other:
• Placebo
A trial of exercise before and after 4 weeks of placebo administration.

Locations

Country	Name	City	State
Greece	Department of Physical Education & Sport Science of the University of Thessaly	Trikala	Karyes

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. ?-lipoic acid supplementation up-regulates antioxidant capacity in adults with G6PD deficiency. Food Chem Toxicol. 2013 Nov;61:69-73. doi: 10.1016/j.fct.2013.01.055. Epub 2013 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in redox status after exercise	Indices of blood redox status	Before, immediately after and 1 hour after each trial of exercise
Secondary	Body composition	Body fat percentage	Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
Secondary	Blood pressure	Blood pressure at rest	Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo