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

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

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

Study Overview

• Status: Unknown
• Conditions: Obesity; Insulin Resistance; Carbohydrate Metabolism Disorder
• Intervention / Treatment: Dietary supplement: NAC group; Dietary supplement: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-624
    • Recruiting
    • Poznan University of Life Sciences
    • Contact: Karolina Łagowska, PhD; Phone Number: +48618487335; Email: karolina.lagowska@up.poznan.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homocysteine concentrations mg/dL	Plasma homocysteine concentrations at baseline and after 12 weeks of the intervention	12 weeks
Glutathione level uM/L	Plasma glutathione concentrations will be measured at baseline and after 12 weeks of the intervention	12 weeks
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
Body height kg	Body height will be assemsment at baseline of the intervention.	baseline
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
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
MTHFR polymorphism	Methylenetetrahydrofolate reductaseMTHFR polymorphism will be measured only at baseline (before intervention).	baseline
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
Cytokine measured	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.	12 weeks
C-Reactive Protein measured	C-Reactive Protein will be measured at baseline and after 12 weeks of the intervention	12 weeks

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Insulin resistance; Nutrition intervention; N - acetylocysteine; Carbohydrate Metabolism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Hyperinsulinism; Insulin Resistance; Metabolic Diseases
• Other Study ID Numbers: PoznanULS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No