UC Davis, Ragle Human Nutrition Center
Davis, California, 95616, United States
NCT Number: NCT01803594
This study involves measuring subject's blood lipid responses after they consume a mixture of dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake, on three separate days. The investigators hope to learn more about how different food ingredients influence the metabolism HDL in individuals with low blood levels of HDL cholesterol.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
This study a partial randomized crossover study designed to determine how consumption of bioactive dietary ingredients in various combinations on three separate test days influences postprandial lipoprotein metabolism in participants with low circulating HDL-cholesterol.
The dietary ingredients include:
Dairy phospholipids(PC700); krill oil (K); lutein (L); and Niacin
Eligible participants will arrive to the University of California Davis (UC Davis), Ragle Human Nutrition Center on the morning of each test day after a 10-12-hr overnight fast. Upon arrival participants will fill out a questionnaire about their dietary and medication intakes and physical activity for the past 72 hours to ensure compliance. Compliant participants' weight and blood pressure will be measured and a fasting blood draw will be taken before participants consume their test meal in the form of a milkshake (control, PC700KL, PC700KL + Niacin). On each test day, participants will be given only this meal and provided with ample supply of bottled water.
Participants will only consume this test meal and water freely for the duration of the test day. Blood will be drawn serially at 2 and 4 hours postprandially. Participants will also be asked to provide 3 urine samples throughout the study: before and 2, and 4 hours after consumption of the milkshake. Participants will be tested on two additional separate test days after the first day separated by a two-week washout. The first two test days will be randomized, however the third test day will always contain niacin in order to require participants remain at Ragle for the first two hours of the study to monitor niacin flushing reactions. Participants have the option of participating in two out of three of the test days if they wish to exclude themselves from the niacin test day.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neptune Krill Oil Gold
Jarrow Formulas
Natures Way
PC700 manufactured by Fonterra
Control shake without dietary supplements
Time frame: 0, 2, 4 hour postprandial
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)
Time frame: 0, 2, 4 hours postprandial
HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.
Time frame: 0, 2, 4 hours
Urinary metabolites will be measured by NMR spectroscopy.
Time frame: 0, 2, 4 hours postprandially
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.
University of California, Davis
Other
Postprandial Modulation of HDL Metabolism
Acronym: HDL
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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