NCT03481608

Brief Summary

A phosphatidylcholine species enriched with lauric acid at both the sn-1 and sn-2 positions, dilauroylphosphatidylcholine (DLPC), was recently identified as a ligand for the nuclear receptor, liver receptor homolog-1 (LRH-1). To date, DLPC has not been reported in vitro or in vivo, and has yet to be catalogued in the human metabolomics database. This intervention trial aims to determine the impact of consumption of dietary lauric acid, in the form of coconut oil (49% lauric acid), can facilitate the production of DLPC in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

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

First Submitted

Initial submission to the registry

March 8, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

March 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2018

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

24 days

First QC Date

March 8, 2018

Last Update Submit

March 8, 2022

Conditions

Keywords

fatty acidnutritionmetabolismlauric aciddilauroylphosphatidylcholinelrh-1

Outcome Measures

Primary Outcomes (1)

  • DLPC in Postprandial Serum

    The presence of DLPC in postprandial serum will be measured using Liquid Chromatography Tandem Mass Spectrometry

    6 hours postprandial

Secondary Outcomes (1)

  • Serum Total Bile Acids

    6 hours postprandial

Study Arms (2)

Olive Oil Shake

ACTIVE COMPARATOR

Intervention: No Lauric Acid A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of olive oil.

Other: No Lauric acid (olive oil)

Coconut Oil Shake

EXPERIMENTAL

Intervention: Lauric Acid A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of coconut oil.

Other: Lauric acid (coconut oil)

Interventions

A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of coconut oil.

Coconut Oil Shake

A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of olive oil.

Olive Oil Shake

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willingness to comply with the study protocol
  • Ability to overnight fast
  • Willingness to donate blood
  • 'generally healthy'

You may not qualify if:

  • self-reported regular consumption of tropical oils or supplements containing lauric acid
  • self-reported food allergies to shake ingredients
  • medical conditions where blood draws or fasting may be contraindicated
  • major gastrointestinal conditions, such as inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

Location

MeSH Terms

Interventions

lauric acidCoconut OilOlive Oil

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsDietary Fats, UnsaturatedFats, UnsaturatedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the intervention oil (single-blind).
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Acute feeding study. Participants will arrive at our Human Metabolic Research Unit on 2 separate occasions. Participants will be randomized to consume 1 of 2 shake on each occasion. Shakes will be prepared with 2 tablespoons of either control (olive) or intervention (coconut) oils.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 29, 2018

Study Start

March 19, 2018

Primary Completion

April 12, 2018

Study Completion

April 22, 2018

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations