Weight Loss Effect on Circulating Liver Enzymes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Visceral Fat, Liver Dysfunction

Intervention / Treatment
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* Behavioral: Control group
* Behavioral: Weight loss group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>No calorie restriction group | Behavioral: Control group<br>* The participants who included in control group did not receive any treatment.<br>|
| Experimental: Weight loss group<br>Mild calorie restriction group (300kcal/day intake reduction) | Behavioral: Weight loss group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral fat area at L4 (CT) |  | At baseline | 
| Visceral fat area at L4 (CT) |  | At 12-week follow-up | 
| 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 | 
| Serum fatty acid levels (Relative peak area) |  | At 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat percentage (DEXA) |  | At baseline | 
| Fat percentage (DEXA) |  | At 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 | 
| Fat mass (DEXA) |  | At 12-week follow-up | 
| Change from baseline fat mass at 12-week (DEXA) |  | At baseline and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High visceral fat, Liver enzymes, Aminotransferase, Mild calorie restriction