NCT02937363

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

October 12, 2016

Last Update Submit

November 2, 2017

Conditions

G6PD Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in redox status after exercise

    Indices of blood redox status

    Before, immediately after and 1 hour after each trial of exercise

Secondary Outcomes (2)

  • Body composition

    Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo

  • Blood pressure

    Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo

Study Arms (2)

Alpha-lipoic acid

EXPERIMENTAL

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

Dietary Supplement: Alpha-lipoic acid

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Alpha-lipoic acidDIETARY_SUPPLEMENT

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

Alpha-lipoic acid
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • G6PD deficiency

You may not qualify if:

  • Any uncontrolled health condition for which exercise is contraindicated
  • Current use of dietary supplements or drugs
  • Pregnant, pregnancy intention or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trikala, Karyes, 42100, Greece

Location

Related Publications (2)

  • 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.

    PMID: 23416142BACKGROUND

  • 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.

    PMID: 34389161DERIVED

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Athanasios Z Jamurtas, PhD

    University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

GR(1)