Skip to main content
OpenTrials
Completed

NCT Number: NCT02992639

Weight Loss Effect on Circulating Liver Enzymes

To investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²].

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University

Seoul, 03722, South Korea

About this study

A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high VFA. The participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The randomization was according to computer-generated block randomization (placebo:test = 1:1). Before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to give informed consent
  • 20-60 years old
  • Males and females
  • Overweight (25.0 kg/m²≤ BMI <30 kg/m²)
  • Absence of pregnancy or breast-feeding
  • Stable body weight (body weight change <1kg for 3 months before screening)
  • High visceral fat (VFA) at L4 (VFA at L4 ≥100 cm²)
  • Without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease
  • No use medication affecting body weight, energy expenditure, or glucose control for the last 6 months

Exclusion criteria

  • Prior history of Cushing syndrome or malignancy
  • Prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease
  • Excess alcohol intake (based on WHO standard)
  • History of intentional reduction in weight in the preceding 6 months

Treatment and study plan

Control Group

Behavioral

The participants who included in control group did not receive any treatment.

Weight loss group

Behavioral

The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes

Primary outcomes

  1. Visceral fat area at L4 (CT)

    Time frame: At baseline

  2. Visceral fat area at L4 (CT)

    Time frame: At 12-week follow-up

  3. Change from baseline visceral fat area at L4 at 12-week (CT)

    Time frame: At baseline and 12-week follow-up

  4. Serum fatty acid levels (Relative peak area)

    Time frame: At baseline

  5. Serum fatty acid levels (Relative peak area)

    Time frame: At 12-week follow-up

Secondary outcomes

  1. Fat percentage (DEXA)

    Time frame: At baseline

  2. Fat percentage (DEXA)

    Time frame: At 12-week follow-up

  3. Change from baseline fat percentage at 12-week (DEXA)

    Time frame: At baseline and 12-week follow-up

  4. Fat mass (DEXA)

    Time frame: At baseline

  5. Fat mass (DEXA)

    Time frame: At 12-week follow-up

  6. Change from baseline fat mass at 12-week (DEXA)

    Time frame: At baseline and 12-week follow-up

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2016
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.