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

NCT01710280 | Completed

• 1 other identifier: IRIS
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Men; Raised Fasting Plasma Triacylglycerol Concentrations

Keywords

Lipemia; Vascular function; Blood pressure

Outcome Measures

Primary Outcomes (1)

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

  1-6 h post-meal

Secondary Outcomes (3)

• Incremental AUC for plasma non-esterified fatty acid concentrations

  1-6 h post-meal

• Changes from baseline in digital volume pulse

  2,4,5,6 h post-meal

• Changes from baseline in blood pressure

  2,4,5,6 h post-meal

Other Outcomes (1)

• Incremental AUC for plasma total cholesterol concentrations

  1-6 h post-meal

Study Arms (2)

Native palm olein

ACTIVE COMPARATOR

75 g native palm olein

Dietary Supplement: High-fat meal containing native palm olein

Interesterified palm olein

EXPERIMENTAL

75 g interesterified palm olein

Dietary Supplement: High-fat meal containing interesterified palm olein

Interventions

High-fat meal containing native palm olein DIETARY_SUPPLEMENT

Native palm olein

High-fat meal containing interesterified palm olein DIETARY_SUPPLEMENT

Interesterified palm olein

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

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

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.

  PMID: 22030225 BACKGROUND

Related Links

• Primary publication

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

GB (1)