Clinical trial NCT02992639: Weight Loss Effect on Circulating Liver Enzymes
Official title: Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Fat
Liver Dysfunction
Keywords: High visceral fat
Liver enzymes
Aminotransferase
Mild calorie restriction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visceral fat area at L4 (CT)
timeFrame: At baseline
measure: Visceral fat area at L4 (CT)
timeFrame: At 12-week follow-up
measure: Change from baseline visceral fat area at L4 at 12-week (CT)
timeFrame: At baseline and 12-week follow-up
measure: Serum fatty acid levels (Relative peak area)
timeFrame: At baseline
measure: Serum fatty acid levels (Relative peak area)
timeFrame: At 12-week follow-up
Secondary outcomes:
measure: Fat percentage (DEXA)
timeFrame: At baseline
measure: Fat percentage (DEXA)
timeFrame: At 12-week follow-up
measure: Change from baseline fat percentage at 12-week (DEXA)
timeFrame: At baseline and 12-week follow-up
measure: Fat mass (DEXA)
timeFrame: At baseline
measure: Fat mass (DEXA)
timeFrame: At 12-week follow-up
measure: Change from baseline fat mass at 12-week (DEXA)
timeFrame: At baseline and 12-week follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Lee A, Yoo HJ, Kim M, Kim M, Jee SH, Shin DY, Lee JH. Effect of weight loss on circulating fatty acid profiles in overweight subjects with high visceral fat area: a 12-week randomized controlled trial. Nutr J. 2018 Feb 22;17(1):28. doi: 10.1186/s12937-018-0323-4.