Healthy Men Clinical Trial
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 |
Verified date | September 2019 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Diabetes & Nutritional Sciences Division, King's College London. | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
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
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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