Diet ModificationDLauricPCNCT03481608
The Effect of Dietary Lauric Acid on the Production of the LRH-1 Ligand, Dilauroylphosphatidylcholine
A study testing Lauric acid (coconut oil) and No Lauric acid (olive oil) in people with Diet Modification, run by Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Lauric acid (coconut oil) and No Lauric acid (olive oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 22 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to comply with the study protocol
- Ability to overnight fast
- Willingness to donate blood
- 'generally healthy'
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolic Research Unit, Cornell University
Ithaca, New York, 14853
About this study
Official title: 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.
Read the 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
- Being tested
- Lauric acid (coconut oil), No Lauric acid (olive oil)
- Keywords
- fatty acid, nutrition, metabolism, lauric acid, dilauroylphosphatidylcholine, lrh-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Lauric acid (coconut oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLPC in Postprandial Serum
The presence of DLPC in postprandial serum will be measured using Liquid Chromatography Tandem Mass Spectrometry
Measured: 6 hours postprandial
Secondary outcomes (1)
Serum Total Bile Acids
Serum total bile acids may be measured following shake consumption using a colorimetric assay.
Measured: 6 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start19 Mar 2018
- Primary completion12 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481608
- Sponsor's protocol ID
- 1802007735
- Acronym
- DLauricPC
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data, including mass spectra, can be made available upon request.
Publications
Klatt KC, Fontenot L, Dong B, Patel P, Malysheva OV, Brenna JT, Roberson MS, Hartig SM, Caudill MA, Moore DD. Provision of Lauric Acid Results in Endogenous Production of the Liver Receptor Homolog-1 Ligand, Dilauroylphosphatidylcholine, and Evidence of LRH-1 Transactivation. J Nutr. 2026 Oct 12:101880. doi: 10.1016/j.tjnut.2026.101880. Online ahead of print.
PubMed 42863609
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of a LRH-1 Ligand in Humans: A Randomized,Controlled, Cross-Over Feeding Trial
- ClinicalTrials.gov ID
- NCT03481608
- Acronym / sponsor ID
- DLauricPC / 1802007735
- Conditions
- Diet Modification
- Keywords
- fatty acid, nutrition, metabolism, lauric acid, dilauroylphosphatidylcholine, lrh-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Olive Oil Shake | Active comparator | Other: No Lauric acid (olive oil)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. |
| Coconut Oil Shake | Experimental | Other: Lauric acid (coconut oil)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willingness to comply with the study protocol
- Ability to overnight fast
- Willingness to donate blood
- 'generally healthy'
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Coconut Oil Shake |
| 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. | Other | Olive Oil Shake |
Primary outcome
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
1 secondary outcome
Serum Total Bile Acids
Time frame: 6 hours postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 42863609Klatt KC, Fontenot L, Dong B, Patel P, Malysheva OV, Brenna JT, Roberson MS, Hartig SM, Caudill MA, Moore DD. Provision of Lauric Acid Results in Endogenous Production of the Liver Receptor Homolog-1 Ligand, Dilauroylphosphatidylcholine, and Evidence of LRH-1 Transactivation. J Nutr. 2026 Oct 12:101880. doi: 10.1016/j.tjnut.2026.101880. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Deidentified data, including mass spectra, can be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lauric acid (coconut oil) and No Lauric acid (olive oil) in people with Diet Modification, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLPC in Postprandial Serum (time frame: 6 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.