Effects of MCDG Oil on Postprandial Lipid Metabolism

Hyperlipidemias Clinical Trial

Official title:

The Effects of Functional Edible Oil (MCDG) on Reducing Body Fat of Overweight or Obesity Subjects (Part.2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415568
• Other study ID #: DOP_OFTT
• Status: Completed
• Phase: N/A
• First received: January 15, 2018
• Last updated: January 29, 2018
• Start date: June 30, 2017
• Est. completion date: July 28, 2017

Study information

• Verified date: January 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertriglyceridemia
• Triglycerides High

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride levels	Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake	6 hours
Secondary	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)
Secondary	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)