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

Sponsor

University of California, Davis (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01803594

Collaborator

Unilever R&D (Industry)

Enrollment

Location

Arms

175.3

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Dietary Supplement: Krill Oil Dietary Supplement: Lutein Dietary Supplement: Nicotinic acid Dietary Supplement: Dairy phospholipids Other: Control	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Postprandial Modulation of HDL Metabolism

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jan 2, 2013

Anticipated Study Completion Date :

Mar 13, 2027

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Shake Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder.	Other: Control Control shake without dietary supplements
Active Comparator: PC700, Krill Oil, and Lutein Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water. Neptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 = dairy lipids (Fonterra brand)	Dietary Supplement: Krill Oil Neptune Krill Oil Gold Dietary Supplement: Lutein Jarrow Formulas Dietary Supplement: Dairy phospholipids PC700 manufactured by Fonterra
Active Comparator: PC700, Krill Oil, Lutein, and Niacin Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water. Nicotinic acid was added to each shake prior to consumption at a doses 5mg/kg of body weight. Neptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 (Fonterra); Nicotinic acid (Natures Way)	Dietary Supplement: Krill Oil Neptune Krill Oil Gold Dietary Supplement: Lutein Jarrow Formulas Dietary Supplement: Nicotinic acid Natures Way Dietary Supplement: Dairy phospholipids PC700 manufactured by Fonterra

Arm

Intervention/Treatment

Placebo Comparator: Control Shake

Other: Control

Control shake without dietary supplements

Active Comparator: PC700, Krill Oil, and Lutein

Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water. Neptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 = dairy lipids (Fonterra brand)

Dietary Supplement: Krill Oil

Neptune Krill Oil Gold

Dietary Supplement: Lutein

Jarrow Formulas

Dietary Supplement: Dairy phospholipids

PC700 manufactured by Fonterra

Active Comparator: PC700, Krill Oil, Lutein, and Niacin

Each shake delivers 30% of each participant's calculated energy expenditure and provides 45% energy as fat, 40% energy as carbohydrate and 15% energy as protein. The shake contains whipping cream, frozen fruit, glucose polymer, and protein powder. Fifty percent of the fat is made up of PC700. Additionally, 3.0g Krill oil and 40mg of lutein capsules are swallowed with water. Nicotinic acid was added to each shake prior to consumption at a doses 5mg/kg of body weight. Neptune Krill Oil capsules (Nutrigold); Lutein capsules (Jarrow Formulas); PC700 (Fonterra); Nicotinic acid (Natures Way)

Dietary Supplement: Krill Oil

Neptune Krill Oil Gold

Dietary Supplement: Lutein

Jarrow Formulas

Dietary Supplement: Nicotinic acid

Natures Way

Dietary Supplement: Dairy phospholipids

PC700 manufactured by Fonterra

Outcome Measures

Primary Outcome Measures

Plasma lipoprotein profile [0, 2, 4 hour postprandial]
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)

Secondary Outcome Measures

Plasma HDL proteome [0, 2, 4 hours postprandial]
HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.
Urinary metabolomics [0, 2, 4 hours]
Urinary metabolites will be measured by NMR spectroscopy.
Red blood cell functionality [0, 2, 4 hours postprandially]
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65 years
Plasma HDL cholesterol (Less than 50 mg/dL)

Exclusion Criteria:

History of gastrointestinal disorders like Crohns disease, colitis, irritable bowel syndrome
History of cardiovascular events: stroke, heart attack, cardiac arrhythmia
History of peptic ulcers, gastritis
History of gout
History of being under care of any psychiatric conditions (schizophrenia and depression associated with response to niacin)
Cancer
Type 1 or 2 diabetes
Known presence of significant metabolic disease which could impact results of study (hepatic, renal disease)
Low blood pressure (defined as 3 consecutive readings below 100/60 mmHg at screening)
Self report skin sensitivities; self report to rash easily
Self report to hot flashes currently experience due to menopause
Hypersensitivity to niacin
Muscle disorders such as myasthenia gravis
Pending surgery within the next 3 months
Known allergy to study food (shellfish, fish, nut, soy)
Known intolerance to study food (lactose intolerance)
More than 1 serving of fish per week
Intake of anti-inflammatory supplemental fish, krill, borage, flax, and primrose seed oils within the last 12 weeks
Intake of dietary supplements consisting of concentrated soy isoflavones, resveratrol, other dietary polyphenols identified as modulators of lipids within the last 12 weeks
Intake of more than 20 mg of lutein and zeaxanthin per week
Intake of nicotinic acid (niacin) within the last 12 weeks
Intake of anti-coagulants, blood pressure or heart medications within the last 12 weeks
Plan to become pregnant in next 6 months
Recent initiation (past 4 weeks) of exercise program
Use of tobacco products
Excessive alcohol consumption (2 drinks/day for men and 1 drink/day for women)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis, Ragle Human Nutrition Center	Davis	California	United States	95616

Sponsors and Collaborators

University of California, Davis
Unilever R&D

Investigators

Principal Investigator: Jennifer T Smilowitz, PhD, University of California, Davis
Principal Investigator: J. Bruce German, PhD, University of California, Davis