Clinical Trials Directory

Trials / Completed

CompletedNCT01803594

Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism

Postprandial Modulation of HDL Metabolism

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKrill OilNeptune Krill Oil Gold
DIETARY_SUPPLEMENTLuteinJarrow Formulas
DIETARY_SUPPLEMENTNicotinic acidNatures Way
DIETARY_SUPPLEMENTDairy phospholipidsPC700 manufactured by Fonterra
OTHERControlControl shake without dietary supplements

Timeline

Start date
2012-08-01
Primary completion
2013-01-02
Completion
2015-03-13
First posted
2013-03-04
Last updated
2022-09-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01803594. Inclusion in this directory is not an endorsement.