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The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC group | Experimental | NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder |
|
| Control group | Active Comparator | Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAC group | Dietary Supplement | Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people). |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance | Fasting insulin concentration (uU/ml) will be measured before and after 2 hours of 75g glucose drink. Insulin resistance will be measured before and after 12 weeks of the intervention. | 12 weeks |
| Oral glucose toletance test OGTT | Fasting glucose concentration (mg/dL) will be measured before and after 2 hours of 75g glucose drink. OGTT test will be measured before and after 12 weeks of the intervention. Fasting glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Homocysteine concentrations mg/dL | Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention | 12 weeks |
| Glutathione level uM/L | Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Life Sciences | Recruiting | Poznan | 60-624 | Poland |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Randomized Controlled Trails
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| Control group | Dietary Supplement | Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people). |
|
| 12 weeks |
| Body weight kg | Body weight will be assemsment at baseline and after 4,8 and12 weeks of the intervention. Weight and height will be combined to report BMI in kg/m^2. | 12 weeks |
| Body height kg | Body height will be assemsment at baseline of the intervention. | baseline |
| Body mass index kg/m2 | BMI (body mass index kg/m2) will be assemsment at baseline and after 4, 8 and 12 weeks of the intervention. | 12 weeks |
| Body composition | Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention. | 12 weeks |
| MTHFR polymorphism | Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention). | baseline |
| Blood lipoproteins measured. | Blood lipid profile: cholesterol mg/dL, low-density lipoprotein LDL mg/dL, high-density lipoprotein HDL mg/dL, triglycerides mg/dL will be measured at baseline and after 12 weeks of the intervention. | 12 weeks |
| Cytokine measured | Cytokine: IL-6 pg/ml, IL- 10 pg/ml, TNF - α pg/ml will be measured at baseline and after 12 weeks of the intervention. | 12 weeks |
| C-Reactive Protein measured | C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention | 12 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |