Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
- Conditions
- Carbohydrate Metabolism DisorderG6PD DeficiencyOxidative Stress
- Interventions
- Dietary Supplement: Alpha-lipoic acidOther: Placebo
- Registration Number
- NCT05571748
- Lead Sponsor
- University of Thessaly
- 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 diabetic individuals with G6PD deficiency, after acute exercise.
- Detailed Description
In a randomized double-blind, crossover design, a total of forty people will participate in the research voluntarily: (a) ten people with G6PD (Mediterranean type) enzyme deficiency), (b) ten people with G6PD (Mediterranean type) enzyme deficiency and a disorder of carbohydrate metabolism (diabetes, prediabetes), (c) ten people with a disorder of carbohydrate metabolism (diabetes mellitus and prediabetes) and, (d) ten people without any health problem (control group). They will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition) or placebo (control condition) every day for 4 weeks, separated by a 4-week washout period. All participants will be randomly assigned to both conditions.
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 VO2peak test will be performed.
Participants will perform a trial of exercise (70% VO2peak for 45min and 90% till exhaustion) before and after each condition (i.e. a total of 4 trials). Blood samples will be collected before, immediately after and 1 hour after each exercise trial. Moreover, measurements of anthropometric characteristics, physiological and psychological parameters will be performed before and after each condition.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Individuals with normal G6PD activity
- Individuals with G6PD deficiency
- Individuals with CHO metabolism disorders (diabetes, prediabetes)
- Individuals with G6PD deficiency and CHO metabolism disorders (diabetes, prediabetes)
- Health problems that contraindicate participation to exercise
- Should not take any medication that affects the body's antioxidant mechanisms as well as dietary supplements containing antioxidants
- Women during lactation or gestation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description G6PD deficiency (only) - Intervention Alpha-lipoic acid Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals. G6PD deficiency (only) - Placebo Placebo Placebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals. G6PD deficiency and CHO metabolism disorder - Intervention Alpha-lipoic acid Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. Controls - Intervention Alpha-lipoic acid Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder. G6PD deficiency and CHO metabolism disorder - Placebo Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. CHO metabolism disorder (only) - Intervention Alpha-lipoic acid Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. CHO metabolism disorder (only) - Placebo Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. Controls - Placebo Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder.
- Primary Outcome Measures
Name Time Method Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DTNB method.
Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.
Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DPPH method.
Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DNPH method.
Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.
Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.
Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Blood lipids (total cholesterol, LDL-c, HDH-c, triglycerides). Spectrophotometric assays for the determination of blood lipids using a clinical chemistry analyzer with commercially available kits.
Changes in insulin resistance following 4 weeks of supplementation and placebo. Before and following 4 weeks of supplementation and placebo. Measurement of blood glucose and insulin levels to assess HOMA-IR and evaluate insulin resistance. Spectrophotometric assay for the determination of blood glucose using a clinical chemistry analyzer with commercially available kits.Determination of blood insulin using commercially available Eliza kits.
Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo. Before and following 4 weeks of supplementation and placebo. Measurement of HbA1c using commercially available kits.
- Secondary Outcome Measures
Name Time Method Changes in body mass index following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Body mass (in kg) and height (in cm)
Changes in resting heart rate following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Resting heart rate (beats per minute) measurement after at least 5 minutes at rest
Changes in body composition following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Body fat mass (in kg) and percentage, lean mass (in kg) and percentage
Changes in waist-to-hip ratio following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Measurement of waist and hip circumference to calculate waist-to-hip ratio
Changes in blood pressure following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest
Changes in complete blood count following 4 weeks of intervention and placebo. Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Complete blood count
Changes in psychometric test following 4 weeks of intervention and placebo. Before and following 4 weeks of supplementation and placebo. Hospital Anxiety Depression Scale-HADS (Greek version)
Trial of VO2peak estimation. Before intervention. VO2peak (mL/kg body weight/min) estimation with a treadmill protocol.
Superoxide dismutases (SOD) Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Spectrophotometric assay for the determination of SOD in erythrocytes.
Nicotinamide-adenine dinucleotide phosphate (NADPH) Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Spectrophotometric assay for the determination of NADPH in erythrocytes.
Glutathione Reductase (GR) Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Spectrophotometric assay for the determination of GR in erythrocytes.
Glutathione peroxidase (GPx) Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) Spectrophotometric assay for the determination of GPx in erythrocytes.
G6PD enzyme activity in erythrocytes Before intervention. During GTT (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). Also before, immediately after and 1, 2, 24 hours after each trial of exercise, in both conditions (supplement and placebo). Quantification of G6PD activity in erythrocytes (units/gram of hemoglobin) of all participants using a commercially available kit.
Glucose Tolerance Test (GTT) Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). GTT for the investigation of changes in glucose control.