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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD deficiency (only) - Intervention | Experimental | Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals. |
|
| G6PD deficiency (only) - Placebo | Placebo Comparator | Placebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals. |
|
| G6PD deficiency and CHO metabolism disorder - Intervention | Experimental | 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. |
|
| G6PD deficiency and CHO metabolism disorder - Placebo | Placebo Comparator | Placebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. |
|
| CHO metabolism disorder (only) - Intervention | Experimental | Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-lipoic acid | Dietary Supplement | A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DPPH method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DTNB method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition following 4 weeks of intervention and placebo. | Body fat mass (in kg) and percentage, lean mass (in kg) and percentage | Before and following 4 weeks of supplementation and placebo. |
| Changes in body mass index following 4 weeks of intervention and placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athanasios Z Jamurtas, PhD | Contact | 2431047054 | +30 | ajamurt@pe.uth.gr |
| Athanasios Gatsas, MSc | Contact | 6971559250 | +30 | t.gatsas@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Athanasios Z Jamurtas, PhD | University of Thessaly | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23416142 | Background | 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. |
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| ID | Term |
|---|---|
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| CHO metabolism disorder (only) - Placebo | Placebo Comparator | Placebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
|
| Controls - Intervention | Experimental | 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. |
|
| Controls - Placebo | Placebo Comparator | Placebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder. |
|
|
| Placebo | Other | A trial of acute exercise before and after 4 weeks of placebo supplementation. |
|
|
| Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DNPH method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in insulin resistance 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. | Before and following 4 weeks of supplementation and placebo. |
| Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo. | Measurement of HbA1c using commercially available kits. | Before and following 4 weeks of supplementation and placebo. |
Body mass (in kg) and height (in cm) |
| Before and following 4 weeks of supplementation and placebo. |
| Changes in resting heart rate following 4 weeks of intervention and placebo. | Resting heart rate (beats per minute) measurement after at least 5 minutes at rest | Before and following 4 weeks of supplementation and placebo. |
| Changes in blood pressure following 4 weeks of intervention and placebo. | Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest | Before and following 4 weeks of supplementation and placebo. |
| Changes in waist-to-hip ratio following 4 weeks of intervention and placebo. | Measurement of waist and hip circumference to calculate waist-to-hip ratio | Before and following 4 weeks of supplementation and placebo. |
| Changes in complete blood count following 4 weeks of intervention and placebo. | Complete blood count | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Changes in psychometric test following 4 weeks of intervention and placebo. | Hospital Anxiety Depression Scale-HADS (Greek version) | Before and following 4 weeks of supplementation and placebo. |
| Trial of VO2peak estimation. | VO2peak (mL/kg body weight/min) estimation with a treadmill protocol. | Before intervention. |
| Nicotinamide-adenine dinucleotide phosphate (NADPH) | Spectrophotometric assay for the determination of NADPH in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Glutathione Reductase (GR) | Spectrophotometric assay for the determination of GR in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Glutathione peroxidase (GPx) | Spectrophotometric assay for the determination of GPx in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Superoxide dismutases (SOD) | Spectrophotometric assay for the determination of SOD in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) |
| Glucose Tolerance Test (GTT) | GTT for the investigation of changes in glucose control. | Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). |
| G6PD enzyme activity in erythrocytes | Quantification of G6PD activity in erythrocytes (units/gram of hemoglobin) of all participants using a commercially available kit. | 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). |
| D006425 |
| Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |