Interaction of Genetic and Environmental Factors for Body Fat Mass Control

Completed

• Conditions: Unrecognized Condition
• Interventions: Behavioral: lifestyle

• Registration Number: NCT04299698
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Primary Completion: 2017-09-18
• Study Completion: 2018-02-19
• Status Verified: 2020-03
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carbohydrate reduction group	lifestyle	Participants chose to control their body fat mass by reducing their carbohydrate intake through observation study periods.
Moderate exercise group	lifestyle	Participants chose to control their body fat mass by moderately increasing the time and intensity of exercise through observation study periods.
Intense exercise group	lifestyle	Participants chose to control their body fat mass by vigorously increasing the time and intensity of exercise through observation study periods.
Fat reduction group	lifestyle	Participants chose to control their body fat mass by reducing their fat intake through observation study periods.

Primary Outcome Measures

Name	Time	Method
Change of body fat mass	baseline and 14 weeks	Anthropometric data including body fat mass were measured by InBody720 --assessing whole and segmental body composition.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of