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

U

University of Thessaly

Status

Completed

Conditions

G6PD Deficiency

Treatments

Other: Placebo
Dietary Supplement: Alpha-lipoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02937363
UTH_G6PD

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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