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Weight Loss Effect on Circulating Liver Enzymes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992639
Enrollment
80
Registered
2016-12-14
Start date
2015-06-30
Completion date
2016-10-31
Last updated
2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Dysfunction, Visceral Fat

Keywords

High visceral fat, Liver enzymes, Aminotransferase, Mild calorie restriction

Brief summary

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 \[visceral fat area (VFA) at L4 ≥ 100 cm²\].

Detailed 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.

Interventions

BEHAVIORALControl group

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

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Visceral fat area at L4 (CT)At baseline
Change from baseline visceral fat area at L4 at 12-week (CT)At baseline and 12-week follow-up
Serum fatty acid levels (Relative peak area)At baseline

Secondary

MeasureTime frame
Fat percentage (DEXA)At baseline
Change from baseline fat mass at 12-week (DEXA)At baseline and 12-week follow-up
Change from baseline fat percentage at 12-week (DEXA)At baseline and 12-week follow-up
Fat mass (DEXA)At baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026