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

Sponsor
University of Thessaly (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02937376
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: N-acetyl cystein
  • Other: Placebo
 Early Phase 1

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
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: N-acetyl Cystein

NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

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

    		•
    Placebo Comparator: Placebo

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Body composition [Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo]

      Body fat percentage

    2. Blood pressure [Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo]

      Blood pressure at rest

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Physical Education & Sport Science of the University of Thessaly Trikala Karyes Greece 42100

    Sponsors and Collaborators

    • University of Thessaly

    Investigators

    • Study Director: Athanasios Z Jamurtas, PhD, University of Thessaly

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Athanasios Z. Jamurtas, Professor, University of Thessaly
    ClinicalTrials.gov Identifier:
    NCT02937376
    Other Study ID Numbers:
    • UTH_G6PD 2
    First Posted:
    Oct 18, 2016
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glucosephosphate Dehydrogenase Deficiency

    Study Results

    No Results Posted as of Jan 5, 2022