Carbohydrate Metabolism Disorder, Insulin Resistance, Obesity
Conditions
Keywords
N - acetylocysteine, Obesity, Insulin resistance, Nutrition intervention, Carbohydrate Metabolism
Brief summary
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
Interventions
DIETARY_SUPPLEMENTNAC group
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).
DIETARY_SUPPLEMENTControl group
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).
Sponsors
Poznan University of Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized Controlled Trails
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* women diagnosed with carbohydrate metabolism disorder, * obesity (BMI \>29,9 kg/m2) * patients not participating in other similar research programs at the same time, * written agreement to take part in the research.
Exclusion criteria
* the use of medicament that may affect on carbohydrate metabolism within 4 weeks, * failure to comply with dietary recommendations established during the nutritional intervention, * pregnancy and breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Resistance | 12 weeks | 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. |
| Oral glucose toletance test OGTT | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight kg | 12 weeks | 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. |
| Body height kg | baseline | Body height will be assemsment at baseline of the intervention. |
| Body mass index kg/m2 | 12 weeks | BMI (body mass index kg/m2) will be assemsment at baseline and after 4, 8 and 12 weeks of the intervention. |
| Body composition | 12 weeks | Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention. |
| Homocysteine concentrations mg/dL | 12 weeks | Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention |
| Blood lipoproteins measured. | 12 weeks | 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. |
| Cytokine measured | 12 weeks | 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. |
| C-Reactive Protein measured | 12 weeks | C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention |
| MTHFR polymorphism | baseline | Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention). |
| Glutathione level uM/L | 12 weeks | Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention |
Countries
Poland
Outcome results
None listed