The Effect of Dietary Lauric Acid on the Production of the LRH-1 Ligand, Dilauroylphosphatidylcholine (DLauricPC)

March 8, 2022 updated by: Cornell University

Production of a LRH-1 Ligand in Humans: A Randomized,Controlled, Cross-Over Feeding Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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). LRH-1 has notable roles in regulating sterol metabolism, with downstream impacts on reproductive capacity, bile acid production, glucose metabolism, and cell proliferation. Manipulation of LRH-1 activity via ligand-inducing binding and activation has the potential to act as a therapy in certain metabolic disorders, such as type 2 diabetes. To date, the LRH-1 ligand, DLPC, has not been reported in vitro or in vivo, and has yet to be indexed in the Human Metabolomics Database, suggesting that it's therapeutic potential is limited to pharmacological administration. The investigators' forthcoming unpublished research tested the hypothesis that the lack of DLPC in physiological systems results from substrate insufficiency, and have observed that consumption of dietary lauric acid facilitates the production of DLPC in animal models, and addition of lauric acid to the culture media of cells additionally leads to its production. A single acute gavage of coconut oil results in the production of DLPC in the intestine and export in the serum 1-2 hours post-gavage. To extend this work to humans, the investigators are undertaking an acute, randomized, cross-over trial of dietary lauric acid consumption. This intervention trial aims to determine whether dietary lauric acid, in the form of coconut oil (49% lauric acid), can facilitate the production of DLPC in humans. The investigators have hypothesized that consumption of a single breakfast shake containing coconut oil will result in DLPC in post-prandial serum. Participants will be invited to the Cornell University Human Metabolic Research Unit (HMRU) on 2 separate occasions to consume 1 of 2 breakfast shake , delivered in random order. Shakes will be made with either 2 tablespoons of olive oil (control) or coconut oil (intervention). Participants will arrive to the HMRU fasted and provide a baseline blood sample, prior to consumption of the breakfast shake ; at 2, 4, and 6 hours following the meal, participants will provide additional blood samples. Prior to and throughout the duration of the study, participants will be asked to avoid consumption of tropical oils. Lauric acid is typically a minimal component of the common diet, though substantial intakes can occur with the consumption of tropical oils, such as coconut oil or palm kernel oil. Lauric acid is considered one of the three primary hypercholesterolemic saturated fatty acids and is currently not recommended to constitute a major component of the diet; participants for whom a cholesterol lowering diet is recommended will not be able to enroll in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14853
        • Human Metabolic Research Unit, Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Olive Oil Shake

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)
A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of olive oil.
Experimental: Coconut Oil Shake

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLPC in Postprandial Serum
Time Frame: 6 hours postprandial
The presence of DLPC in postprandial serum will be measured using Liquid Chromatography Tandem Mass Spectrometry
6 hours postprandial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Total Bile Acids
Time Frame: 6 hours postprandial
Serum total bile acids may be measured following shake consumption using a colorimetric assay.
6 hours postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1802007735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Deidentified data, including mass spectra, can be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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