Dietary Sources of Lysophospholipids

NCT02952638 | Terminated DMC

• 1 other identifier: 14-1001-FIV
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Cardiovascular Risk Factor; Hyperlipidemia

Keywords

Lipids; lysophosphatidic acid; Lysophospholipids; phosphatidylcholine; lysophosphatidylcholine; autotaxin; dietary

Outcome Measures

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.

  8 hours

Study Arms (3)

Healthy

BMI is between 20 and 25

Overweight

BMI is between 25 and 30

Obese

BMI is between 30 and 40

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Susan Smyth: lead

Study Sites (1)

University of Kentucky Dept of Cardiology

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples to measure lysophosphilipid levels

MeSH Terms

Conditions

Obesity; Hyperlipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Susan S Smyth, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: November 2, 2016
• Study Start: July 14, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)