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OpenTrials
Completed

NCT Number: NCT01710280

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

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.

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Key information

Conditions

Healthy Men Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Raised Fasting Plasma Triacylglycerol Concentrations

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Nutritional Sciences Division, King's College London.

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

High-fat meal containing native palm olein

Dietary Supplement

High-fat meal containing interesterified palm olein

Dietary Supplement

Primary outcomes

  1. Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations

    Time frame: 1-6 h post-meal

Secondary outcomes

  1. Incremental AUC for plasma non-esterified fatty acid concentrations

    Time frame: 1-6 h post-meal

  2. Changes from baseline in digital volume pulse

    Time frame: 2,4,5,6 h post-meal

  3. Changes from baseline in blood pressure

    Time frame: 2,4,5,6 h post-meal

Other outcomes

  1. Incremental AUC for plasma total cholesterol concentrations

    Time frame: 1-6 h post-meal

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 19, 2012
Registry last updated
Sep 16, 2019

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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