Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
Dyslipidemia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 incl...

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.

Tracking Information

NCT #
NCT01803594
Collaborators
Unilever R&D
Investigators
Principal Investigator: Jennifer T Smilowitz, PhD University of California, Davis Principal Investigator: J. Bruce German, PhD University of California, Davis