Interaction of Genetic and Environmental Factors for Body Fat Mass Control

Interaction of Genetic and Environmental Factors for Body Fat Mass Control: Observational Study for Lifestyle Modification and Genotyping

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.

Study Overview

• Status: Completed
• Conditions: Unrecognized Condition
• Intervention / Treatment: Behavioral: lifestyle

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age from 19 to 65

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carbohydrate reduction group; Participants chose to control their body fat mass by reducing their carbohydrate intake through observation study periods.	Behavioral: lifestyle; Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
Fat reduction group; Participants chose to control their body fat mass by reducing their fat intake through observation study periods.	Behavioral: lifestyle; Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
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; Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
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; Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Samsung Semiconductor R&D center
• Investigators: Study Chair: Woong-Yang Park, MD, Samsung Genomic Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): February 19, 2018

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017-03-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A plan is undecided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No