Weight Loss Effect on Circulating Liver Enzymes

NCT ID: NCT02992639

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

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.

Conditions

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Visceral Fat Liver Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

No calorie restriction group

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type BEHAVIORAL

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

Weight loss group

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

Group Type EXPERIMENTAL

Weight loss group

Intervention Type BEHAVIORAL

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

Interventions

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Control group

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

Intervention Type 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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong Ho Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Yonsei University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 29471812 (View on PubMed)

Other Identifiers

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VFA_liver enzyme

Identifier Type: -

Identifier Source: org_study_id

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