N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women

Obesity Clinical Trial

Official title:

Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902327
• Other study ID #: PoznanULS
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carbohydrate Metabolism Disorder
• Insulin Resistance
• Metabolic Diseases
• Obesity

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