NCT04299698

Brief Summary

Although the effect of interaction between genetic and environmental factors on body fat mass (BFM) has been proposed, how lifestyle changes affect body weight with regard to the genetic composition needs to be verified. The investigators designed an observational study, consisting of healthy adults with single nucleotide polymorphism (SNP) genotyping and longitudinal monitoring of lifestyle including food consumption and physical activities. The investigators recruited the participants who desired to control their body fat mass. Participants freely choose one of the options among carbohydrate intake reduction, fat intake reduction or exercise amount increment to control their body fat mass. Their lifelog on exercise and diet were collected, using a wearable device, for three months. Further, the investigators assessed anthropometric and serologic markers to measure the effect of participant's lifestyle modification. The investigators evaluate the influence of genetic compositions on body fat reduction induced by lifestyle change. Four different genome-wide polygenic scores (GPS) of volunteers are calculated to test the genetic effects of each modification. In this lifestyle observational study, the investigators expect to validate the interaction of genetic and environmental factors in determining BFM, and implicate the healthcare utility of lifestyle modifications using personalized and genomic perspective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

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 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 4, 2020

Last Update Submit

March 5, 2020

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

  • Change of body fat mass

    Anthropometric data including body fat mass were measured by InBody720 --assessing whole and segmental body composition.

    baseline and 14 weeks

Study Arms (4)

Carbohydrate reduction group

Participants chose to control their body fat mass by reducing their carbohydrate intake through observation study periods.

Behavioral: lifestyle

Fat reduction group

Participants chose to control their body fat mass by reducing their fat intake through observation study periods.

Behavioral: lifestyle

Intense exercise group

Participants chose to control their body fat mass by vigorously increasing the time and intensity of exercise through observation study periods.

Behavioral: lifestyle

Moderate exercise group

Participants chose to control their body fat mass by moderately increasing the time and intensity of exercise through observation study periods.

Behavioral: lifestyle

Interventions

lifestyleBEHAVIORAL

Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.

Carbohydrate reduction groupFat reduction groupIntense exercise groupModerate exercise group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are all lived in South Korea in Seoul and Kyeonggi-do.

You may qualify if:

  • Age from 19 to 65

You may not qualify if:

  • Among those reveal to participate one who is under diabetes condition were excluded on the study.
  • Pregnant women
  • Participants taking weight control pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Officials

  • Woong-Yang Park, MD

    Samsung Genomic Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Samsung Genomic institute

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

June 7, 2017

Primary Completion

September 18, 2017

Study Completion

February 19, 2018

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

KR(1)