Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2023
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJanuary 5, 2022
January 1, 2022
4 months
October 12, 2016
January 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in redox status after exercise
Indices of blood redox status
Before, immediately after and 1 hour after each trial of exercise
Secondary Outcomes (2)
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 Arms (2)
N-acetyl Cystein
EXPERIMENTALNAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Placebo
PLACEBO COMPARATORPlacebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Interventions
A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.
Eligibility Criteria
You may qualify if:
- G6PD deficiency
You may not qualify if:
- Any uncontrolled health condition for which exercise is contraindicated
- Current use of dietary supplements or drugs
- Pregnant, pregnancy intention or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Education & Sport Science of the University of Thessaly
Trikala, Karyes, 42100, Greece
Related Publications (1)
Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. Alpha-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.
PMID: 23416142BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Athanasios Z Jamurtas, PhD
University of Thessaly
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 18, 2016
Study Start
February 1, 2023
Primary Completion
June 1, 2023
Study Completion
November 1, 2023
Last Updated
January 5, 2022
Record last verified: 2022-01