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Weight Loss Effect on Circulating Liver Enzymes

Primary Purpose

Visceral Fat, Liver Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Control group

Weight loss group

About this trial

This is an interventional treatment trial for Visceral Fat focused on measuring High visceral fat, Liver enzymes, Aminotransferase, Mild calorie restriction

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Weight loss group

Arm Description

No calorie restriction group

Mild calorie restriction group (300kcal/day intake reduction)

Outcomes

Primary Outcome Measures

Visceral fat area at L4 (CT)

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

Serum fatty acid levels (Relative peak area)

Secondary Outcome Measures

Fat percentage (DEXA)

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

Fat mass (DEXA)

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

Full Information

NCT ID

NCT02992639

First Posted

December 11, 2016

Last Updated

February 14, 2017

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02992639

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visceral Fat, Liver Dysfunction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

No calorie restriction group

Arm Title

Weight loss group

Arm Type

Experimental

Arm Description

Mild calorie restriction group (300kcal/day intake reduction)

Intervention Type

Behavioral

Intervention Name(s)

Control group

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Weight loss group

Intervention Description

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

Primary Outcome Measure Information:

Title

Visceral fat area at L4 (CT)

Time Frame

At baseline

Title

Visceral fat area at L4 (CT)

Time Frame

At 12-week follow-up

Title

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

Time Frame

At baseline and 12-week follow-up

Title

Serum fatty acid levels (Relative peak area)

Time Frame

At baseline

Title

Serum fatty acid levels (Relative peak area)

Time Frame

At 12-week follow-up

Secondary Outcome Measure Information:

Title

Fat percentage (DEXA)

Time Frame

At baseline

Title

Fat percentage (DEXA)

Time Frame

At 12-week follow-up

Title

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

Time Frame

At baseline and 12-week follow-up

Title

Fat mass (DEXA)

Time Frame

At baseline

Title

Fat mass (DEXA)

Time Frame

At 12-week follow-up

Title

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

Time Frame

At baseline and 12-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Ho Lee, PhD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29471812

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.

Results Reference

derived

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Weight Loss Effect on Circulating Liver Enzymes

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