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Weight Loss Effect on Circulating Liver Enzymes

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Yonsei University

Status

Completed

Conditions

Visceral Fat
Liver Dysfunction

Treatments

Behavioral: Weight loss group
Behavioral: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT02992639
VFA_liver enzyme

Details and patient eligibility

About

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].

Full description

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.

Enrollment

80 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
No calorie restriction group
Treatment:
Behavioral: Control group
Weight loss group
Experimental group
Description:
Mild calorie restriction group (300kcal/day intake reduction)
Treatment:
Behavioral: Weight loss group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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