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

Primary Purpose

G6PD Deficiency

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Greece
Study Type
Interventional
Intervention
N-acetyl cystein
Placebo
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for G6PD Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Education & Sport Science of the University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetyl Cystein

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in redox status after exercise
Indices of blood redox status

Secondary Outcome Measures

Body composition
Body fat percentage
Blood pressure
Blood pressure at rest

Full Information

First Posted
October 12, 2016
Last Updated
January 3, 2022
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT02937376
Brief Title
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Official Title
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
G6PD Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetyl Cystein
Arm Type
Experimental
Arm Description
NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Intervention Type
Drug
Intervention Name(s)
N-acetyl cystein
Other Intervention Name(s)
Trebon
Intervention Description
A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A trial of exercise before and after 4 weeks of placebo administration.
Primary Outcome Measure Information:
Title
Change in redox status after exercise
Description
Indices of blood redox status
Time Frame
Before, immediately after and 1 hour after each trial of exercise
Secondary Outcome Measure Information:
Title
Body composition
Description
Body fat percentage
Time Frame
Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
Title
Blood pressure
Description
Blood pressure at rest
Time Frame
Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Z Jamurtas, PhD
Phone
+30-2431047054
Email
ajamurt@pe.uth.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Kalliopi Georgakouli, PhD
Phone
+30-2431047055
Email
kgeorgakouli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Z Jamurtas, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Education & Sport Science of the University of Thessaly
City
Trikala
State/Province
Karyes
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23416142
Citation
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.
Results Reference
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Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise

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