Clinical trial NCT02937363: Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise
Official title: Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: G6PD Deficiency
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of alpha-lipoic acid 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 600 mg of alpha-lipoic acid (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.

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

Primary outcomes:
measure: Change in redox status after exercise
timeFrame: Before, immediately after and 1 hour after each trial of exercise
Secondary outcomes:
measure: Body composition
timeFrame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
measure: Blood pressure
timeFrame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Department of Physical Education & Sport Science of the University of Thessaly
state: Karyes
Study officials:
affiliation: University of Thessaly
name: Athanasios Z Jamurtas, PhD
role: STUDY_DIRECTOR
References:
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.
citation: Garcia AA, Koperniku A, Ferreira JCB, Mochly-Rosen D. Treatment strategies for glucose-6-phosphate dehydrogenase deficiency: past and future perspectives. Trends Pharmacol Sci. 2021 Oct;42(10):829-844. doi: 10.1016/j.tips.2021.07.002. Epub 2021 Aug 10.