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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710280
Other study ID # IRIS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date June 2012

Study information

Verified date September 2019
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Healthy Men
  • Raised Fasting Plasma Triacylglycerol Concentrations

Intervention

Dietary Supplement:
High-fat meal containing native palm olein

High-fat meal containing interesterified palm olein


Locations

Country Name City State
United Kingdom Diabetes & Nutritional Sciences Division, King's College London. London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Incremental AUC for plasma total cholesterol concentrations 1-6 h post-meal
Primary Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations 1-6 h post-meal
Secondary Incremental AUC for plasma non-esterified fatty acid concentrations 1-6 h post-meal
Secondary Changes from baseline in digital volume pulse 2,4,5,6 h post-meal
Secondary Changes from baseline in blood pressure 2,4,5,6 h post-meal
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