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NCT04299698 Clinical Trial

Interaction of Genetic and Environmental Factors for Body Fat Mass Control

Unrecognized Condition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04299698
Other study ID # 2017-03-064
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 7, 2017
Est. completion date February 19, 2018

Study information
Verified date March 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 259
Est. completion date February 19, 2018
Est. primary completion date September 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Samsung Medical Center Samsung Semiconductor R&D center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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