G6PD DeficiencyEarly Phase 1NCT02937376
Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
A Early Phase 1 study testing N-acetyl cystein in people with G6PD Deficiency, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- G6PD Deficiency
- What is being tested?
- N-acetyl cystein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2023to 1 Nov 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- G6PD deficiency
Who cannot join
- Any uncontrolled health condition for which exercise is contraindicated
- Current use of dietary supplements or drugs
- Pregnant, pregnancy intention or breast feeding
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education & Sport Science of the University of Thessaly
Trikala, Karyes, 42100
About this study
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.
Read the 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.
- Conditions
- G6PD Deficiency
- Being tested
- N-acetyl cystein, Placebo
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteinDrug
Also called Trebon
A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.
PlaceboOther
A trial of exercise before and after 4 weeks of placebo administration.
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl Cystein | Experimental | NAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. Receives: Drug: N-acetyl cystein |
| Placebo | Placebo comparator | Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in redox status after exercise
Indices of blood redox status
Measured: Before, immediately after and 1 hour after each trial of exercise
Secondary outcomes (2)
Body composition
Body fat percentage
Measured: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
Blood pressure
Blood pressure at rest
Measured: Before and after 4 weeks of NAC supplementation, before and after 4 weeks of placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z Jamurtas, PhD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937376
- Sponsor's protocol ID
- UTH_G6PD 2
- Status last verified
- Jan 2022
- First submitted
- 12 Oct 2016
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23416142
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-acetyl Cystein (NAC) Supplementation in G6PD Deficient Individuals After Acute Exercise
- ClinicalTrials.gov ID
- NCT02937376
- Acronym / sponsor ID
- UTH_G6PD 2
- Conditions
- G6PD Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl Cystein | Experimental | Drug: N-acetyl cysteinNAC supplementation (10 mg/kg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- G6PD deficiency
Key exclusion criteria (3 listed)
- Any uncontrolled health condition for which exercise is contraindicated
- Current use of dietary supplements or drugs
- Pregnant, pregnancy intention or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteinAlso: TrebonA trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation. | Drug | N-acetyl Cystein |
| PlaceboA trial of exercise before and after 4 weeks of placebo administration. | Other | Placebo |
Primary outcome
Change in redox status after exercise
Time frame: Before, immediately after and 1 hour after each trial of exercise
Indices of blood redox status
2 secondary outcomes
Body composition
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 23416142Georgakouli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z Jamurtas, PhD study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing N-acetyl cystein in people with G6PD Deficiency, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athanasios Z Jamurtas, PhD (+30-2431047054, ajamurt@pe.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in redox status after exercise (time frame: Before, immediately after and 1 hour after each trial of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.