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

November 2, 2017 updated by: Athanasios Z. Jamurtas, University of Thessaly
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Karyes
      • Trikala, Karyes, Greece, 42100
        • Department of Physical Education & Sport Science of the University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha-lipoic acid
Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Dietary supplement: Alpha-lipoic acid
A trial of exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Placebo Comparator: Placebo
Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.
Other: Placebo
A trial of exercise before and after 4 weeks of placebo administration.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
Body fat percentage
Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo
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
Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTH_G6PD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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