Visceral FatNCT02992639
Weight Loss Effect on Circulating Liver Enzymes
A study testing Weight loss group in people with Visceral Fat and Liver Dysfunction, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²]. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Fat, Liver Dysfunction
- What is being tested?
- Weight loss group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to give informed consent
- 20-60 years old
- Males and females
- Overweight (25.0 kg/m²≤ BMI <30 kg/m²)
- Absence of pregnancy or breast-feeding
- Stable body weight (body weight change <1kg for 3 months before screening)
Show all 9Show fewer
- High visceral fat (VFA) at L4 (VFA at L4 ≥100 cm²)
- Without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease
- No use medication affecting body weight, energy expenditure, or glucose control for the last 6 months
Who cannot join
- Prior history of Cushing syndrome or malignancy
- Prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease
- Excess alcohol intake (based on WHO standard)
- History of intentional reduction in weight in the preceding 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial
To investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²].
Read the detailed description
A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high VFA. The participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The randomization was according to computer-generated block randomization (placebo:test = 1:1). Before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.
- Conditions
- Visceral Fat, Liver Dysfunction
- Being tested
- Control group, Weight loss group
- Keywords
- High visceral fat, Liver enzymes, Aminotransferase, Mild calorie restriction
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
The participants who included in control group did not receive any treatment.
Weight loss groupBehavioural
The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | No calorie restriction group Receives: Behavioral: Control group |
| Weight loss group | Experimental | Mild calorie restriction group (300kcal/day intake reduction) Receives: Behavioral: Weight loss 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 from baseline visceral fat area at L4 at 12-week (CT)
Measured: At baseline and 12-week follow-up
Serum fatty acid levels (Relative peak area)
Measured: At baseline
Serum fatty acid levels (Relative peak area)
Measured: At 12-week follow-up
Secondary outcomes (6)
Fat percentage (DEXA)
Measured: At baseline
Fat percentage (DEXA)
Measured: At 12-week follow-up
Change from baseline fat percentage at 12-week (DEXA)
Measured: At baseline and 12-week follow-up
Fat mass (DEXA)
Measured: At baseline
Fat mass (DEXA)
Measured: At 12-week follow-up
Change from baseline fat mass at 12-week (DEXA)
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 posted14 Dec 2016 (estimated)
- 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 (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT02992639
- Sponsor's protocol ID
- VFA_liver enzyme
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
Publications
Lee YJ, Lee A, Yoo HJ, Kim M, Kim M, Jee SH, Shin DY, Lee JH. Effect of weight loss on circulating fatty acid profiles in overweight subjects with high visceral fat area: a 12-week randomized controlled trial. Nutr J. 2018 Feb 22;17(1):28. doi: 10.1186/s12937-018-0323-4.
PubMed 29471812
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02992639
- Acronym / sponsor ID
- VFA_liver enzyme
- Conditions
- Visceral Fat, Liver Dysfunction
- Keywords
- High visceral fat, Liver enzymes, Aminotransferase, Mild calorie restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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 investigate weight loss effect with mild calorie restriction on circulating levels of liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral fat area (VFA) at L4 ≥ 100 cm²].
Detailed description
A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight subjects with high VFA. The participants divided into two groups: 12-week mild calorie restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The randomization was according to computer-generated block randomization (placebo:test = 1:1). Before and after intervention period, venous blood samples were obtained from the subjects, and biochemical parameters including circulating liver enzymes were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Control groupNo calorie restriction group |
| Weight loss group | Experimental | Behavioral: Weight loss groupMild calorie restriction group (300kcal/day intake reduction) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to give informed consent
- 20-60 years old
- Males and females
- Overweight (25.0 kg/m²≤ BMI <30 kg/m²)
- Absence of pregnancy or breast-feeding
Key exclusion criteria (4 listed)
- Prior history of Cushing syndrome or malignancy
- Prior history of liver disease including chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, or drug-induced liver disease
- Excess alcohol intake (based on WHO standard)
- History of intentional reduction in weight in the preceding 6 months
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 groupThe participants who included in control group did not receive any treatment. | Behavioural | Control group |
| Weight loss groupThe participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes | Behavioural | Weight loss 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 from baseline visceral fat area at L4 at 12-week (CT)
Time frame: At baseline and 12-week follow-up
Serum fatty acid levels (Relative peak area)
Time frame: At baseline
Serum fatty acid levels (Relative peak area)
Time frame: At 12-week follow-up
6 secondary outcomes
Fat percentage (DEXA)
Time frame: At baseline
Fat percentage (DEXA)
Time frame: At 12-week follow-up
Change from baseline fat percentage at 12-week (DEXA)
Time frame: At baseline and 12-week follow-up
Fat mass (DEXA)
Time frame: At baseline
Fat mass (DEXA)
Time frame: At 12-week follow-up
Change from baseline fat mass at 12-week (DEXA)
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 15 Feb 2017.
- Derived from this study: PubMed 29471812Lee YJ, Lee A, Yoo HJ, Kim M, Kim M, Jee SH, Shin DY, Lee JH. Effect of weight loss on circulating fatty acid profiles in overweight subjects with high visceral fat area: a 12-week randomized controlled trial. Nutr J. 2018 Feb 22;17(1):28. doi: 10.1186/s12937-018-0323-4.
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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.
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 Weight loss group in people with Visceral Fat and Liver Dysfunction, 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 9 inclusion and 4 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 15 Feb 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 5 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 NCT02992639, which also lists 1 linked publication.
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 15 Feb 2017.