Weight Loss Effect on Circulating Liver Enzymes

Yonsei University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Visceral Fat Liver Dysfunction

Interventions

Control groupBEHAVIORAL

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

Weight loss groupBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University

Seoul, South Korea

Outcomes

Primary Outcomes

Visceral fat area at L4 (CT)

Time frame: At baseline

Visceral fat area at L4 (CT)

Time frame: At 12-week follow-up

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

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

Serum fatty acid levels (Relative peak area)

Time frame: At baseline

Serum fatty acid levels (Relative peak area)

Time frame: At 12-week follow-up

Secondary Outcomes

Fat percentage (DEXA)

Time frame: At baseline

Fat percentage (DEXA)

Time frame: At 12-week follow-up

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

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

Fat mass (DEXA)

Time frame: At baseline

Fat mass (DEXA)

Time frame: At 12-week follow-up

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

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

Data from ClinicalTrials.gov

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