- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937363
Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karyes
-
Trikala, Karyes, Greece, 42100
- Department of Physical Education & Sport Science of the University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Glucosephosphate Dehydrogenase Deficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
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.
Clinical Trials on G6PD Deficiency
-
Baebies, Inc.CompletedG6PD Deficiency | G6PDUnited States
-
University of OxfordCompletedHealthy | G6PD Normal | G6PD DeficientThailand
-
University of Mississippi, OxfordUniversity of Colorado, Denver; Southern Research InstituteUnknown
-
University of ThessalyNot yet recruiting
-
Fundação de Medicina Tropical Dr. Heitor Vieira...Ministry of Health, Brazil; Medicines for Malaria Venture; Centro de Pesquisa... and other collaboratorsActive, not recruitingMalaria, Vivax | G6PD DeficiencyBrazil
-
Dr. Prayuth SudathipMedicines for Malaria VentureCompletedMalaria, Vivax | G6PD DeficiencyThailand
-
PATHFred Hutchinson Cancer CenterCompletedG6PD DeficiencyUnited States
-
PATHCompletedG6PD DeficiencyUnited States
-
PATHFundação de Medicina Tropical Dr. Heitor Vieira DouradoCompleted
-
Columbia UniversityNew York Blood CenterCompleted
Clinical Trials on Alpha-lipoic acid
-
InVasc Therapeutics, Inc.CompletedHypertension | DiabetesUnited States
-
Khyber Medical University PeshawarActive, not recruitingPeripheral Diabetic NeuropathyPakistan
-
Rebecca SpainCompletedComparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisProgressive Multiple Sclerosis | Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Heba Allah Ali Abd El-Halim MabroukTanta UniversityUnknown
-
Seoul St. Mary's HospitalGlaxoSmithKlineTerminatedNASH (Non-alcoholic Steato-hepatitis)
-
Augusta UniversityXinjiang Medical UniversityCompletedObesity | Cardiovascular Disease | Type 2 DiabetesChina
-
Oregon State UniversityOregon Health and Science University; National Center for Complementary and...Active, not recruiting
-
University Health Network, TorontoCanadian Diabetes AssociationCompletedType 2 Diabetes | PrediabetesCanada
-
University of British ColumbiaRecruitingObstructive Sleep Apnea of AdultCanada