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Completed

NCT Number: NCT02937363

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

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.

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Key information

Conditions

G6PD Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Education & Sport Science of the University of Thessaly

Trikala, Karyes, 42100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-lipoic acid

Dietary Supplement

A trial of exercise before and after 4 weeks of alpha-lipoic acid supplementation.

Placebo

Other

A trial of exercise before and after 4 weeks of placebo administration.

Primary outcomes

  1. 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 outcomes

  1. Body composition

    Time frame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo

    Body fat percentage

  2. 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

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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