HyperlipidemiasNCT03415568
Effects of MCDG Oil on Postprandial Lipid Metabolism
A study testing LCT oil and MCDG oil in people with Hyperlipidemias and Triglycerides High, run by Yonsei University at 1 site in South Korea.
Trial summary
It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs). Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Triglycerides High
- What is being tested?
- LCT oil and MCDG oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jun 2017to 28 Jul 2017
- 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 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with normal body weight (18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2)
Who cannot join
- history/presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease, liver disease, gastrointestinal disease, thyroid disease, or any other acute or chronic diseases requiring treatment
- Use of any medication affecting body weight or energy expenditure for 1 month before screening
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 03722
About this study
Official title: The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)
It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs).
Read the detailed description
A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal body weight [18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2] were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the first visit, the participants were randomly assigned to consume a test or placebo product [test product: muffins containing MCDG oil (MCDG muffin); placebo product: muffins containing LCT oil (LCT muffin)] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and 6 hr) of the products.
- Conditions
- Hyperlipidemias, Triglycerides High
- Being tested
- LCT oil, MCDG oil
- Keywords
- Postprandial lipid metabolism, Medium-chain triglycerides, Diacylglycerols, Serum triglycerides, Chylomicron triglycerides
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCT oilDietary supplement
LCT muffin was provided to the study participants. The LCT muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was LCT.
MCDG oilDietary supplement
MCDG muffin was provided to the study participants. The MCDG muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was MCDG.
| Study group | Role | What they receive |
|---|---|---|
| LCT consumption | Placebo comparator | Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test. Receives: Dietary Supplement: LCT oil |
| MCDG consumption | Experimental | Muffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test. Receives: Dietary Supplement: MCDG oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride levels
Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake
Measured: 6 hours
Secondary outcomes (2)
The areas under the curve (AUC) of triglycerides
Triglyceride AUC differences between LCT and MCDG muffins intake
Measured: 1 day of second visit (after finishing cross-over trial)
Triglyceride maximum concentration time
The time when triglyceride peaks maximum concentration during the 6-h meal tolerance test
Measured: 1 day of second visit (after finishing cross-over trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start30 Jun 2017
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- Jong Ho Lee, Ph.D, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415568
- Sponsor's protocol ID
- DOP_OFTT
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)
- ClinicalTrials.gov ID
- NCT03415568
- Acronym / sponsor ID
- DOP_OFTT
- Conditions
- Hyperlipidemias, Triglycerides High
- Keywords
- Postprandial lipid metabolism, Medium-chain triglycerides, Diacylglycerols, Serum triglycerides, Chylomicron triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 30 Jan 2018 (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.
It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs).
Detailed description
A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal body weight [18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2] were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the first visit, the participants were randomly assigned to consume a test or placebo product [test product: muffins containing MCDG oil (MCDG muffin); placebo product: muffins containing LCT oil (LCT muffin)] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and 6 hr) of the products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCT consumption | Placebo comparator | Dietary Supplement: LCT oilMuffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test. |
| MCDG consumption | Experimental | Dietary Supplement: MCDG oilMuffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with normal body weight (18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2)
Key exclusion criteria (2 listed)
- history/presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease, liver disease, gastrointestinal disease, thyroid disease, or any other acute or chronic diseases requiring treatment
- Use of any medication affecting body weight or energy expenditure for 1 month before screening
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 |
|---|---|---|
| LCT oilLCT muffin was provided to the study participants. The LCT muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was LCT. | Dietary supplement | LCT consumption |
| MCDG oilMCDG muffin was provided to the study participants. The MCDG muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was MCDG. | Dietary supplement | MCDG consumption |
Primary outcome
Triglyceride levels
Time frame: 6 hours
Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake
2 secondary outcomes
The areas under the curve (AUC) of triglycerides
Time frame: 1 day of second visit (after finishing cross-over trial)
Triglyceride maximum concentration time
Time frame: 1 day of second visit (after finishing cross-over trial)
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 30 Jan 2018.
- Individual participant dataSharing planned: No
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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, Ph.D 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 LCT oil and MCDG oil in people with Hyperlipidemias and Triglycerides High, 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 1 inclusion and 2 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 30 Jan 2018. 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?
Triglyceride levels (time frame: 6 hours). 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 30 Jan 2018.