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

NCT ID: NCT02937363

Last Updated: 2017-11-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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G6PD Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alpha-lipoic acid

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

Group Type EXPERIMENTAL

Alpha-lipoic acid

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Alpha-lipoic acid

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Athanasios Z. Jamurtas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athanasios Z Jamurtas, PhD

Role: STUDY_DIRECTOR

University of Thessaly

Locations

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

Trikala, Karyes, Greece

Site Status

Countries

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Greece

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.

Reference Type BACKGROUND
PMID: 23416142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34389161 (View on PubMed)

Other Identifiers

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UTH_G6PD

Identifier Type: -

Identifier Source: org_study_id