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TerminatedNCT02952638Updated Jul 21, 2021

Dietary Sources of Lysophospholipids

An observational study in Obesity, Cardiovascular Risk Factor and Hyperlipidemia, sponsored by Susan Smyth. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by Susan Smyth · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study aims to test the hypothesis that dietary intake of phosphatidylcholine (PC) and lysophosphatidylcholine (LPC) acutely alters plasma lysophosphatidic acid (LPA) levels and autotaxin activity in normal weight and obese subjects.

Read the detailed description

Lysophosphatidic acid (LPA) is a simple glycerophospholipid that is found at biologically-relevant levels in plasma and has important effects on isolated or cultured blood, vascular and fat cells. The main enzyme responsible for generation of plasma LPA is the secreted lysophospholipase D, autotaxin (ATX). Adipocytes contribute substantially to plasma ATX levels. The investigators have demonstrated rapid production and metabolism of plasma LPA in animals. More recently, the investigators have observed that plasma LPA levels increase in mice fed a high fat ("Western") diet in comparison to levels found in mice fed normal chow. The investigators have also found that diet-induced obesity increased circulating ATX levels in mice. The investigators hypothesize that diet, and in particular dietary phosphatidylcholine (PC), may regulate the autotaxin substrate lysophosphatidylcholine (LPC), from which LPA is derived. Obesity may amplify the response by increasing plasma ATX levels and/or activity. The current study will test whether dietary PC in normal weight and obese subjects acutely alters LPA levels and autotaxin activity.

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Conditions studied

  • Obesity
  • Cardiovascular Risk Factor
  • Hyperlipidemia

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Keywords

  • Lipids
  • lysophosphatidic acid
  • Lysophospholipids
  • phosphatidylcholine
  • lysophosphatidylcholine
  • autotaxin
  • dietary
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In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 44 is below the median of 302 across 101 observational studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Susan Smyth is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects 18 years of age or older with no major health issues

Inclusion criteria

  • Age 18 to 60 years old
  • Body Mass Index of 20 and above
  • Must be able to consume a low fat meal, unlimited fruits and vegetables and not eating after midnight the night before the lipid tolerance test
  • Report to the clinical research unit fasting (no food since the meal the night before)
  • Able to consume a liquid meal consisting of a commercial nutritional product supplemented with fat
  • Able to have an indwelling catheter placed on one arm and have hourly blood draws for 8 hours

Exclusion criteria

Exclusion Criteria:

  • Unstable medical condition (recent or unstable cardiovascular disease)
  • Active cancer
  • Renal insufficiency Glomerular Filtration Rate \<30
  • Use of steroids
  • Chronic inflammatory conditions
  • Use of anticoagulants, anti-inflammatory, or lipid-lowering medications
  • Lipodystrophy
  • GI conditions that result in lipid intolerance
  • Pregnant women have a tendency to be anemic and therefore will be excluded.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy

    BMI is between 20 and 25

  • Overweight

    BMI is between 25 and 30

  • Obese

    BMI is between 30 and 40

06

What researchers measure

Primary outcomes

  1. Plasma Autotaxin-dependent formation of Lysophosphatidic acid, and Levels of Phosphatidylcholine and its metabolites - Lysophosphatidylcholine, Lysophosphatidic acid, Choline, Trimethylamine and Trimethylamine oxide measured by Tandem Mass Spectrometry

    Investigators will use tandem mass spectrometry to measure the most abundant metabolite species. Enzymatic activity of autotaxin involves incubation with the substrate lysophosphatidylcholine and monitoring concentration dependent release of lysophosphatidic acid. Levels of Lysophospholipids Phosphatidylcholine and the products of its metabolism in the blood will be measured. Quantitation will be achieved by stable isotope dilution and by reference to offline calibration curves. By using mass spectrometry and metabolic tracers, studies using a common protocol are effectively multiplexed so data on both endogenous and mass labeled lipids can be obtained from a single individual. Given the sensitivity of these analytical methods (limits of quantitation of approximately 1 fmol), the measurements and the quantities will be reported as concentration in picomoles per liter of plasma volume. A statistical correlation with each group based on BMI will be performed.

    Time frame: 8 hours

07

Study locations

1 site
  • University of Kentucky Dept of Cardiology
    Lexington, Kentucky 40536, United States
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References and documents

Individual participant data

Plan to share: No — We do not plan to share individual participant data.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02952638
Lead sponsor
Susan Smyth
Responsible party
Susan Smyth (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
Nov 2, 2016
Start date
Jul 14, 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jul 21, 2021

Study contacts

Susan S Smyth, MD, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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