Visceral FatNCT03135132
The Effect of Mild Weight Loss on Circulating Metabolite Profiles
A study testing LCD group in people with Visceral Fat and Weight Loss, run by Yonsei University at 1 site in South Korea.
Trial summary
To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Fat, Weight Loss
- What is being tested?
- LCD group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Oct 2016
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- 20-65 years old
- Males and females
- Overweight (25.0 kg/m²≤ Body mass index <30 kg/m²)
- Nondiabetic (Fasting glucose <126 mg/dL)
Who cannot join
- Unstable body weight (body weight change >1 kg within 3 months before screening)
- Consumption of medication that affects body weight or energy expenditure
- Pregnancy or breast-feeding
- Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
- Liver disease, kidney disease, or gastrointestinal disease
- Acute or chronic infections
- Any acute or chronic disease requiring treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss
To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.
Read the detailed description
Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).
- Conditions
- Visceral Fat, Weight Loss
- Being tested
- Control group, LCD group
- Keywords
- High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
Recommend to consume usual diet during 12-week study period
LCD groupBehavioural
Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Usual dietary intake group Receives: Behavioral: Control group |
| LCD group | Experimental | Low calorie diet (LCD) group (300kcal/day intake reduction) Receives: Behavioral: LCD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral fat area at L4 (CT)
Measured: At baseline
Visceral fat area at L4 (CT)
Measured: At 12-week follow-up
Change in visceral fat area at L4 from baseline
Measured: At baseline and 12-week follow-up
Putatively identified plasma metabolites (Normalized peak intensities)
Measured: At baseline
Putatively identified plasma metabolites (Normalized peak intensities)
Measured: At 12-week follow-up
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
Measured: At baseline and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visceral FatStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135132
- Sponsor's protocol ID
- Wt loss_metabolites
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.
PubMed 34099056Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.
PubMed 30322392
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss
- ClinicalTrials.gov ID
- NCT03135132
- Acronym / sponsor ID
- Wt loss_metabolites
- Conditions
- Visceral Fat, Weight Loss
- Keywords
- High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 May 2017 (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.
To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.
Detailed description
Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Control groupUsual dietary intake group |
| LCD group | Experimental | Behavioral: LCD groupLow calorie diet (LCD) group (300kcal/day intake reduction) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to give informed consent
- 20-65 years old
- Males and females
- Overweight (25.0 kg/m²≤ Body mass index <30 kg/m²)
- Nondiabetic (Fasting glucose <126 mg/dL)
Key exclusion criteria (7 listed)
- Unstable body weight (body weight change >1 kg within 3 months before screening)
- Consumption of medication that affects body weight or energy expenditure
- Pregnancy or breast-feeding
- Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease
- Liver disease, kidney disease, or gastrointestinal disease
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 |
|---|---|---|
| Control groupRecommend to consume usual diet during 12-week study period | Behavioural | Control group |
| LCD groupRecommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day | Behavioural | LCD group |
Primary outcome
Visceral fat area at L4 (CT)
Time frame: At baseline
Visceral fat area at L4 (CT)
Time frame: At 12-week follow-up
Change in visceral fat area at L4 from baseline
Time frame: At baseline and 12-week follow-up
Putatively identified plasma metabolites (Normalized peak intensities)
Time frame: At baseline
Putatively identified plasma metabolites (Normalized peak intensities)
Time frame: At 12-week follow-up
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baseline
Time frame: At baseline and 12-week follow-up
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 1 May 2017.
- Derived from this study: PubMed 34099056Jang HY, Han Y, Yoo HJ, Lee JH, Kim M. Effects of short-term dietary restriction on plasma metabolites and the subcutaneous fat area according to metabolic status in obese individuals: a case-control study. Diabetol Metab Syndr. 2021 Jun 7;13(1):62. doi: 10.1186/s13098-021-00679-8.
- Derived from this study: PubMed 30322392Kang M, Yoo HJ, Kim M, Kim M, Lee JH. Metabolomics identifies increases in the acylcarnitine profiles in the plasma of overweight subjects in response to mild weight loss: a randomized, controlled design study. Lipids Health Dis. 2018 Oct 15;17(1):237. doi: 10.1186/s12944-018-0887-1.
- Individual participant dataSharing planned: No
Related trials for Visceral Fat
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Overweight, Obesity
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Sleep Deprivation
Recruiting
Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study
Class I Obesity
RecruitingObservational study
Visceral Adipose Tissue and Liver Changes Associated With Semaglutide in CKD
Chronic Kidney Disease in Type 2 Diabetes, Obesity & Overweight
RecruitingObservational study
Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes
Obesity (Disorder), Type 2 Diabetes Mellitus
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.
Jong Ho Lee, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCD group in people with Visceral Fat and Weight Loss, run by Yonsei University 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 5 inclusion and 7 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 1 May 2017. 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. Some participants in this study may receive a placebo. 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?
Visceral fat area at L4 (CT) (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135132, which also lists 2 linked publications.
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 1 May 2017.