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Completed

NCT Number: NCT03481608

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

About this study

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 The investigators' forthcoming unpublished research tested the hypothesis that the lack of DLPC in physiological systems results from substrate insufficiency, and have observed that consumption of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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lauric acid (coconut oil)

Other

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

No Lauric acid (olive oil)

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum Total Bile Acids

    Time frame: 6 hours postprandial

    Serum total bile acids may be measured following shake consumption using a colorimetric assay.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Official study title

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

Acronym: DLauricPC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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