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

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: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Other: No Lauric acid (olive oil); Other: Lauric acid (coconut oil)

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 The investigators' forthcoming unpublished research tested the hypothesis that the lack of DLPC in physiological systems results from substrate insufficiency, and have observed that consumption of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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
DLPC in Postprandial Serum	The presence of DLPC in postprandial serum will be measured using Liquid Chromatography Tandem Mass Spectrometry	6 hours postprandial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Total Bile Acids	Serum total bile acids may be measured following shake consumption using a colorimetric assay.	6 hours postprandial

Collaborators and Investigators

• Sponsor: Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 22, 2018

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: nutrition; metabolism; fatty acid; lauric acid; dilauroylphosphatidylcholine; lrh-1
• Other Study ID 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