Obesity Clinical Trial
Official title:
Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?
Verified date | March 2020 |
Source | Poznan University of Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Life Sciences | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Life Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Homocysteine concentrations mg/dL | Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention | 12 weeks | |
Secondary | Glutathione level uM/L | Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention | 12 weeks | |
Secondary | 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 | |
Secondary | Body height kg | Body height will be assemsment at baseline of the intervention. | baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | MTHFR polymorphism | Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention). | baseline | |
Secondary | 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 | |
Secondary | Cytokine measured | Cytokine: IL-6 pg/ml, IL- 10 pg/ml, TNF - a pg/ml will be measured at baseline and after 12 weeks of the intervention. | 12 weeks | |
Secondary | C-Reactive Protein measured | C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention | 12 weeks |
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