Effects of MCDG Oil on Postprandial Lipid Metabolism

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).

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias; Triglycerides High
• Intervention / Treatment: Dietary supplement: LCT oil; Dietary supplement: MCDG oil

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 29 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: LCT consumption; Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test.	Dietary supplement: LCT oil; 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.
EXPERIMENTAL: MCDG consumption; Muffin that contains 15g of the mixture of medium-chain triglyceride and diacylglycerol (MCDG) oils were provided to conduct 6-h meal tolerance test.	Dietary supplement: MCDG oil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride levels	Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The areas under the curve (AUC) of triglycerides	Triglyceride AUC differences between LCT and MCDG muffins intake	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	1 day of second visit (after finishing cross-over trial)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2017
• Primary Completion (ACTUAL): July 28, 2017
• Study Completion (ACTUAL): July 28, 2017

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Medium-chain triglycerides; Postprandial lipid metabolism; Diacylglycerols; Serum triglycerides; Chylomicron triglycerides
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: DOP_OFTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No