NCT03135132

Brief Summary

To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

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
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 26, 2017

Last Update Submit

April 26, 2017

Conditions

Visceral FatWeight Loss

Keywords

High visceral fatLow calorie dietMild weight lossMetabolomicsMetabolitesAcylcarnitines

Outcome Measures

Primary Outcomes (6)

  • Visceral fat area at L4 (CT)

    At baseline

  • Visceral fat area at L4 (CT)

    At 12-week follow-up

  • Change in visceral fat area at L4 from baseline

    At baseline and 12-week follow-up

  • Putatively identified plasma metabolites (Normalized peak intensities)

    At baseline

  • Putatively identified plasma metabolites (Normalized peak intensities)

    At 12-week follow-up

  • Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline

    At baseline and 12-week follow-up

Study Arms (2)

Control group

PLACEBO COMPARATOR

Usual dietary intake group

Behavioral: Control group

LCD group

EXPERIMENTAL

Low calorie diet (LCD) group (300kcal/day intake reduction)

Behavioral: LCD group

Interventions

Control groupBEHAVIORAL

Recommend to consume usual diet during 12-week study period

Control group
LCD groupBEHAVIORAL

Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day

LCD group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent
  • years old
  • Males and females
  • Overweight (25.0 kg/m²≤ Body mass index \<30 kg/m²)
  • Nondiabetic (Fasting glucose \<126 mg/dL)

You may not qualify if:

  • Unstable body weight (body weight change \>1 kg within 3 months before screening)
  • Consumption of medication that affects body weight or energy expenditure
  • Pregnancy or breast-feeding
  • Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
  • Liver disease, kidney disease, or gastrointestinal disease
  • Acute or chronic infections
  • Any acute or chronic disease requiring treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (2)

  • Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.

    PMID: 34099056DERIVED

  • Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.

    PMID: 30322392DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)