N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03902327 |
Recruitment Status : Unknown
Verified March 2020 by Agata Chmurzyńska, Poznan University of Life Sciences.
Recruitment status was: Recruiting
First Posted : April 4, 2019
Last Update Posted : March 24, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insulin Resistance Obesity Carbohydrate Metabolism Disorder | Dietary Supplement: NAC group Dietary Supplement: Control group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized Controlled Trails |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Does N-acetyl-cysteine Treatment Improves Carbohydrate Metabolism in Obese Women? |
Actual Study Start Date : | January 17, 2020 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: NAC group
NAC for 12 weeks, 1.6 mg/day, 4x400 mg; a diet based on general recommendations for people with carbohydrate metabolism disorder
|
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). |
Active Comparator: Control group
Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder
|
Dietary Supplement: Control group
Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people). |
- Insulin Resistance [ Time Frame: 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 [ Time Frame: 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).
- Homocysteine concentrations mg/dL [ Time Frame: 12 weeks ]Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention
- Glutathione level uM/L [ Time Frame: 12 weeks ]Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention
- Body weight kg [ Time Frame: 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 [ Time Frame: baseline ]Body height will be assemsment at baseline of the intervention.
- Body mass index kg/m2 [ Time Frame: 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 [ Time Frame: 12 weeks ]Fat mass (%) and Fat free mass (%) will be assement at baseline and after 4, 8 and 12 weeks of the intervention.
- MTHFR polymorphism [ Time Frame: baseline ]Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).
- Blood lipoproteins measured. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902327
Poland | |
Poznan University of Life Sciences | Recruiting |
Poznan, Poland, 60-624 | |
Contact: Karolina Łagowska, PhD +48618487335 karolina.lagowska@up.poznan.pl |
Responsible Party: | Agata Chmurzyńska, dr hab, Director of Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences |
ClinicalTrials.gov Identifier: | NCT03902327 |
Other Study ID Numbers: |
PoznanULS |
First Posted: | April 4, 2019 Key Record Dates |
Last Update Posted: | March 24, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
N - acetylocysteine Obesity Insulin resistance Nutrition intervention Carbohydrate Metabolism |
Insulin Resistance Metabolic Diseases Hyperinsulinism Glucose Metabolism Disorders |