Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia

September 12, 2019 updated by: Dr Wendy Hall, King's College London
The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • Diabetes & Nutritional Sciences Division, King's College London.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males
  • Non-smokers
  • Aged 40-70 years
  • Fasting TAG concentrations ≥1.5 mmol/L.

Exclusion Criteria:

  • Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
  • Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
  • History of substance abuse or alcoholism (previous weekly alcohol intake >60 units/men)
  • Current self-reported weekly alcohol intake exceeding 28 units
  • Allergy or intolerance to any component of test meals
  • Unwilling to restrict consumption of any source of fish oil for the length of the study
  • Weight change of >3kg in preceding 2 months
  • Body Mass Index <20 and >35 kg/m2
  • Fasting blood cholesterol > 7.8 mmol/L
  • Current cigarette smoker.
  • Current use of lipid lowering medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Native palm olein
75 g native palm olein
Dietary supplement: High-fat meal containing native palm olein
Experimental: Interesterified palm olein
75 g interesterified palm olein
Dietary supplement: High-fat meal containing interesterified palm olein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations
Time Frame: 1-6 h post-meal
1-6 h post-meal

Secondary Outcome Measures

Outcome Measure
Time Frame
Incremental AUC for plasma non-esterified fatty acid concentrations
Time Frame: 1-6 h post-meal
1-6 h post-meal
Changes from baseline in digital volume pulse
Time Frame: 2,4,5,6 h post-meal
2,4,5,6 h post-meal
Changes from baseline in blood pressure
Time Frame: 2,4,5,6 h post-meal
2,4,5,6 h post-meal

Other Outcome Measures

Outcome Measure
Time Frame
Incremental AUC for plasma total cholesterol concentrations
Time Frame: 1-6 h post-meal
1-6 h post-meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRIS (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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