Unrecognized ConditionNCT04299698
Interaction of Genetic and Environmental Factors for Body Fat Mass Control
An observational study of Unrecognized Condition, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- lifestyle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 259 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2017to 19 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are all lived in South Korea in Seoul and Kyeonggi-do.
Who may be able to join
- Age from 19 to 65
Who cannot join
- Among those reveal to participate one who is under diabetes condition were excluded on the study.
- Pregnant women
- Participants taking weight control pills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Unrecognized Condition
- Being tested
- lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyleBehavioural
Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate reduction group | Participants chose to control their body fat mass by reducing their carbohydrate intake through observation study periods. Receives: Behavioral: lifestyle | |
| Fat reduction group | Participants chose to control their body fat mass by reducing their fat intake through observation study periods. Receives: 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. Receives: 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. Receives: Behavioral: lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body fat mass
Anthropometric data including body fat mass were measured by InBody720 --assessing whole and segmental body composition.
Measured: baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start7 Jun 2017
- Primary completion18 Sep 2017
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Semiconductor R&D center
- Responsible party
- Principal investigator, Woong-Yang Park, Samsung Medical Center
- Investigators
- Woong-Yang Park, MD, Study chair, Samsung Genomic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299698
- Sponsor's protocol ID
- 2017-03-064
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A plan is undecided yet.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Genetic and Environmental Factors for Body Fat Mass Control: Observational Study for Lifestyle Modification and Genotyping
- ClinicalTrials.gov ID
- NCT04299698
- Acronym / sponsor ID
- 2017-03-064
- Conditions
- Unrecognized Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Semiconductor R&D center
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate reduction group | – | Behavioral: lifestyleParticipants chose to control their body fat mass by reducing their carbohydrate intake through observation study periods. |
| Fat reduction group | – | Behavioral: lifestyleParticipants chose to control their body fat mass by reducing their fat intake through observation study periods. |
| Intense exercise group | – | Behavioral: lifestyleParticipants chose to control their body fat mass by vigorously increasing the time and intensity of exercise through observation study periods. |
| Moderate exercise group | – | Behavioral: lifestyleParticipants chose to control their body fat mass by moderately increasing the time and intensity of exercise through observation study periods. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are all lived in South Korea in Seoul and Kyeonggi-do.
Key inclusion criteria (1 listed)
- Age from 19 to 65
Key exclusion criteria (3 listed)
- Among those reveal to participate one who is under diabetes condition were excluded on the study.
- Pregnant women
- Participants taking weight control pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyleParticipants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise. | Behavioural | Carbohydrate reduction group, Fat reduction group, Intense exercise group, Moderate exercise group |
Primary outcome
Change of body fat mass
Time frame: baseline and 14 weeks
Anthropometric data including body fat mass were measured by InBody720 --assessing whole and segmental body composition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided. A plan is undecided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woong-Yang Park, MD study chair
Samsung Genomic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unrecognized Condition, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body fat mass (time frame: baseline and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.