NCT02992639

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 \[visceral fat area (VFA) at L4 ≥ 100 cm²\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
Last Updated

February 15, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 11, 2016

Last Update Submit

February 14, 2017

Conditions

Visceral FatLiver Dysfunction

Keywords

High visceral fatLiver enzymesAminotransferaseMild calorie restriction

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

No calorie restriction group

Behavioral: Control group

Weight loss group

EXPERIMENTAL

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

Behavioral: Weight loss group

Interventions

Control groupBEHAVIORAL

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

Control group
Weight loss groupBEHAVIORAL

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

Weight loss group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to give informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29471812DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jong Ho Lee, PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 14, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 15, 2017

Record last verified: 2017-01

Locations

KR(1)