Weight Loss Effect on Circulating Liver Enzymes

February 14, 2017 updated by: Yonsei University

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

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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VFA_liver enzyme

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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