NCT03902327

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 11, 2019

Last Update Submit

March 23, 2020

Conditions

Insulin ResistanceObesityCarbohydrate Metabolism Disorder

Keywords

N - acetylocysteineObesityInsulin resistanceNutrition interventionCarbohydrate Metabolism

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Homocysteine concentrations mg/dL

    12 weeks

  • Glutathione level uM/L

    12 weeks

  • Body weight kg

    12 weeks

  • Body height kg

    baseline

  • Body mass index kg/m2

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

NAC group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Placebo for 12 weeks and a diet based on general recommendations for people with carbohydrate metabolism disorder

Dietary Supplement: Control group

Interventions

NAC groupDIETARY_SUPPLEMENT

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).

NAC group
Control groupDIETARY_SUPPLEMENT

Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

RECRUITING

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trails
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr hab, Director of Institute of Human Nutrition and Dietetics

Study Record Dates

First Submitted

March 11, 2019

First Posted

April 4, 2019

Study Start

January 17, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

PL(1)