Effects of MCDG Oil on Postprandial Lipid Metabolism
Primary Purpose
Hyperlipidemias, Triglycerides High
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LCT oil
MCDG oil
Sponsored by
About this trial
This is an interventional basic science trial for Hyperlipidemias focused on measuring Postprandial lipid metabolism, Medium-chain triglycerides, Diacylglycerols, Serum triglycerides, Chylomicron triglycerides
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects with normal body weight (18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2)
Exclusion Criteria:
- 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
Sites / Locations
- Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
LCT consumption
MCDG consumption
Arm Description
Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test.
Muffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test.
Outcomes
Primary Outcome Measures
Triglyceride levels
Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake
Secondary Outcome Measures
The areas under the curve (AUC) of triglycerides
Triglyceride AUC differences between LCT and MCDG muffins intake
Triglyceride maximum concentration time
The time when triglyceride peaks maximum concentration during the 6-h meal tolerance test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03415568
Brief Title
Effects of MCDG Oil on Postprandial Lipid Metabolism
Official Title
The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Triglycerides High
Keywords
Postprandial lipid metabolism, Medium-chain triglycerides, Diacylglycerols, Serum triglycerides, Chylomicron triglycerides
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LCT consumption
Arm Type
Placebo Comparator
Arm Description
Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test.
Arm Title
MCDG consumption
Arm Type
Experimental
Arm Description
Muffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test.
Intervention Type
Dietary Supplement
Intervention Name(s)
LCT oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCDG oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triglyceride levels
Description
Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
The areas under the curve (AUC) of triglycerides
Description
Triglyceride AUC differences between LCT and MCDG muffins intake
Time Frame
1 day of second visit (after finishing cross-over trial)
Title
Triglyceride maximum concentration time
Description
The time when triglyceride peaks maximum concentration during the 6-h meal tolerance test
Time Frame
1 day of second visit (after finishing cross-over trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects with normal body weight (18.5 kg/m^2 ≤ body mass index (BMI) < 25 kg/m^2)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, Ph.D
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of MCDG Oil on Postprandial Lipid Metabolism
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