- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937376
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Athanasios Z Jamurtas, PhD
- Phone Number: +30-2431047054
- Email: ajamurt@pe.uth.gr
Study Contact Backup
- Name: Kalliopi Georgakouli, PhD
- Phone Number: +30-2431047055
- Email: kgeorgakouli@gmail.com
Study Locations
-
-
Karyes
-
Trikala, Karyes, Greece, 42100
- Department of Physical Education & Sport Science of the University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
|
A trial of exercise before and after 4 weeks of placebo administration.
|
Experimental: N-acetyl Cystein
NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
|
A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in redox status after exercise
Time Frame: Before, immediately after and 1 hour after each trial of exercise
|
Indices of blood redox status
|
Before, immediately after and 1 hour after each trial of exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
|
Body fat percentage
|
Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
|
Blood pressure
Time Frame: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
|
Blood pressure at rest
|
Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTH_G6PD 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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