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

NCT ID: NCT03481608

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-19
• Study Completion Date: 2018-04-22

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.

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 The investigators' forthcoming unpublished research tested the hypothesis that the lack of DLPC in physiological systems results from substrate insufficiency, and have observed that consumption of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.

Conditions

Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

No Lauric acid (olive oil)

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Lauric acid (coconut oil)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Metabolic Research Unit, Cornell University

Ithaca, New York, United States

Countries

United States

Other Identifiers

1802007735

Identifier Type: -

Identifier Source: org_study_id