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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02937363
Other study ID # UTH_G6PD
Secondary ID
Status Completed
Phase N/A
First received October 12, 2016
Last updated November 2, 2017
Start date December 2016
Est. completion date July 2017

Study information

Verified date November 2017
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Greece Department of Physical Education & Sport Science of the University of Thessaly Trikala Karyes

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. ?-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in redox status after exercise Indices of blood redox status Before, immediately after and 1 hour after each trial of exercise
Secondary Body composition Body fat percentage Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
Secondary Blood pressure Blood pressure at rest Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
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