Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
NCT ID: NCT05571748
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-02-28
2023-06-30
Brief Summary
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Detailed Description
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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 VO2peak test will be performed.
Participants will perform a trial of exercise (70% VO2peak for 45min and 90% till exhaustion) before and after each condition (i.e. a total of 4 trials). Blood samples will be collected before, immediately after and 1 hour after each exercise trial. Moreover, measurements of anthropometric characteristics, physiological and psychological parameters will be performed before and after each condition.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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G6PD deficiency (only) - Intervention
Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals.
Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
G6PD deficiency (only) - Placebo
Placebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals.
Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
G6PD deficiency and CHO metabolism disorder - Intervention
Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder.
Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
G6PD deficiency and CHO metabolism disorder - Placebo
Placebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder.
Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
CHO metabolism disorder (only) - Intervention
Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder.
Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
CHO metabolism disorder (only) - Placebo
Placebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder.
Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Controls - Intervention
Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder.
Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Controls - Placebo
Placebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder.
Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Interventions
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Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with G6PD deficiency
* Individuals with CHO metabolism disorders (diabetes, prediabetes)
* Individuals with G6PD deficiency and CHO metabolism disorders (diabetes, prediabetes)
Exclusion Criteria
* Should not take any medication that affects the body's antioxidant mechanisms as well as dietary supplements containing antioxidants
* Women during lactation or gestation
18 Years
65 Years
ALL
Yes
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Athanasios Z. Jamurtas
Principal Investigator
Principal Investigators
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Athanasios Z Jamurtas, PhD
Role: STUDY_DIRECTOR
University of Thessaly
Central Contacts
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References
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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.
Other Identifiers
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G6PD_Diabetes
Identifier Type: -
Identifier Source: org_study_id
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