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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03902327
Other study ID # PoznanULS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 17, 2020
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source Poznan University of Life Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.


Recruitment information / eligibility

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.

Study Design


Intervention

Dietary Supplement:
NAC 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).
Control group
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).

Locations

Country Name City State
Poland Poznan University of Life Sciences Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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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