Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2017

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.

Interventions

  • Dietary Supplement: Alpha-lipoic acid
    • A trial of exercise before and after 4 weeks of alpha-lipoic acid supplementation.
  • Other: Placebo
    • A trial of exercise before and after 4 weeks of placebo administration.

Arms, Groups and Cohorts

  • Experimental: Alpha-lipoic acid
    • Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
  • Placebo Comparator: Placebo
    • Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

Clinical Trial Outcome Measures

Primary Measures

  • Change in redox status after exercise
    • Time Frame: Before, immediately after and 1 hour after each trial of exercise
    • Indices of blood redox status

Secondary Measures

  • Body composition
    • Time Frame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
    • Body fat percentage
  • Blood pressure
    • Time Frame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
    • Blood pressure at rest

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Thessaly
  • Provider of Information About this Clinical Study
    • Principal Investigator: Athanasios Z. Jamurtas, Professor – University of Thessaly
  • Overall Official(s)
    • Athanasios Z Jamurtas, PhD, Study Director, University of Thessaly

References

Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. Α-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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