NCT03415568

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

28 days

First QC Date

January 15, 2018

Last Update Submit

January 29, 2018

Conditions

HyperlipidemiasTriglycerides High

Keywords

Postprandial lipid metabolismMedium-chain triglyceridesDiacylglycerolsSerum triglyceridesChylomicron triglycerides

Outcome Measures

Primary Outcomes (1)

  • Triglyceride levels

    Triglyceride level differences during the 6-hr meal tolerance test between LCT and MCDG muffins intake

    6 hours

Secondary Outcomes (2)

  • The areas under the curve (AUC) of triglycerides

    1 day of second visit (after finishing cross-over trial)

  • Triglyceride maximum concentration time

    1 day of second visit (after finishing cross-over trial)

Study Arms (2)

LCT consumption

PLACEBO COMPARATOR

Muffin that contains 15g of long-chain triglyceride (LCT) oils were provided to conduct 6-h meal tolerance test.

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.

Dietary Supplement: MCDG oil

Interventions

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.

LCT consumption
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.

MCDG consumption

Eligibility Criteria

Age21 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with normal body weight (18.5 kg/m\^2 ≤ body mass index (BMI) \< 25 kg/m\^2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

HyperlipidemiasHypertriglyceridemia

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jong Ho Lee, Ph.D

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 30, 2018

Study Start

June 30, 2017

Primary Completion

July 28, 2017

Study Completion

July 28, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)