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

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01803594
First received: February 28, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention
Dyslipidemia
Dietary Supplement: Krill Oil
Dietary Supplement: Lutein
Dietary Supplement: Nicotinic acid
Dietary Supplement: Dairy phospholipids
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postprandial Modulation of HDL Metabolism

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma lipoprotein profile [ Time Frame: 0, 2, 4 hour postprandial ] [ Designated as safety issue: No ]
    Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)


Secondary Outcome Measures:
  • Plasma HDL proteome [ Time Frame: 0, 2, 4 hours postprandial ] [ Designated as safety issue: No ]
    HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.

  • Urinary metabolomics [ Time Frame: 0, 2, 4 hours ] [ Designated as safety issue: No ]
    Urinary metabolites will be measured by NMR spectroscopy.

  • Red blood cell functionality [ Time Frame: 0, 2, 4 hours postprandially ] [ Designated as safety issue: No ]
    Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.


Enrollment: 18
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803594

Locations
United States, California
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
  More Information

Additional Information:
Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01803594     History of Changes
Other Study ID Numbers: 264254
Study First Received: February 28, 2013
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Niacin
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 23, 2014