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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Krill Oil
Lutein
Nicotinic acid
Dairy phospholipids
Control
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • UC Davis, Ragle Human Nutrition Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control Shake

PC700, Krill Oil, and Lutein

PC700, Krill Oil, Lutein, and Niacin

Arm Description

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.

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)

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)

Outcomes

Primary Outcome Measures

Plasma lipoprotein profile
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2013
Last Updated
September 28, 2022
Sponsor
University of California, Davis
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01803594
Brief Title
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
Acronym
HDL
Official Title
Postprandial Modulation of HDL Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
January 2, 2013 (Actual)
Study Completion Date
March 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Unilever R&D

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Shake
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
PC700, Krill Oil, and Lutein
Arm Type
Active Comparator
Arm Description
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)
Arm Title
PC700, Krill Oil, Lutein, and Niacin
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill Oil
Intervention Description
Neptune Krill Oil Gold
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein
Intervention Description
Jarrow Formulas
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinic acid
Intervention Description
Natures Way
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy phospholipids
Intervention Description
PC700 manufactured by Fonterra
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control shake without dietary supplements
Primary Outcome Measure Information:
Title
Plasma lipoprotein profile
Description
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)
Time Frame
0, 2, 4 hour postprandial
Secondary Outcome Measure Information:
Title
Plasma HDL proteome
Description
HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.
Time Frame
0, 2, 4 hours postprandial
Title
Urinary metabolomics
Description
Urinary metabolites will be measured by NMR spectroscopy.
Time Frame
0, 2, 4 hours
Title
Red blood cell functionality
Description
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.
Time Frame
0, 2, 4 hours postprandially

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer T Smilowitz, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Bruce German, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis, Ragle Human Nutrition Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19713204
Citation
Dalbeth N, Gracey E, Pool B, Callon K, McQueen FM, Cornish J, MacGibbon A, Palmano K. Identification of dairy fractions with anti-inflammatory properties in models of acute gout. Ann Rheum Dis. 2010 Apr;69(4):766-9. doi: 10.1136/ard.2009.113290. Epub 2009 Aug 26.
Results Reference
background
PubMed Identifier
21524510
Citation
Snow DR, Ward RE, Olsen A, Jimenez-Flores R, Hintze KJ. Membrane-rich milk fat diet provides protection against gastrointestinal leakiness in mice treated with lipopolysaccharide. J Dairy Sci. 2011 May;94(5):2201-12. doi: 10.3168/jds.2010-3886.
Results Reference
background
PubMed Identifier
15531663
Citation
Mozaffarian D, Rimm EB, Herrington DM. Dietary fats, carbohydrate, and progression of coronary atherosclerosis in postmenopausal women. Am J Clin Nutr. 2004 Nov;80(5):1175-84. doi: 10.1093/ajcn/80.5.1175. Erratum In: Am J Clin Nutr. 2005 Jan;81(1):199.
Results Reference
background
PubMed Identifier
12792657
Citation
Tholstrup T, Vessby B, Sandstrom B. Difference in effect of myristic and stearic acid on plasma HDL cholesterol within 24 h in young men. Eur J Clin Nutr. 2003 Jun;57(6):735-42. doi: 10.1038/sj.ejcn.1601605.
Results Reference
background
PubMed Identifier
15656713
Citation
Bunea R, El Farrah K, Deutsch L. Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. 2004 Dec;9(4):420-8.
Results Reference
background
PubMed Identifier
15640510
Citation
Ribaya-Mercado JD, Blumberg JB. Lutein and zeaxanthin and their potential roles in disease prevention. J Am Coll Nutr. 2004 Dec;23(6 Suppl):567S-587S. doi: 10.1080/07315724.2004.10719427.
Results Reference
background
PubMed Identifier
12947433
Citation
Kiokias S, Gordon MH. Dietary supplementation with a natural carotenoid mixture decreases oxidative stress. Eur J Clin Nutr. 2003 Sep;57(9):1135-40. doi: 10.1038/sj.ejcn.1601655.
Results Reference
background
Links:
URL
http://ffhi.ucdavis.edu/human-studies/hdl-metabolic-milkshake
Description
More information about the research is available on the UC Davis Foods for Health Institute's website

Learn more about this trial

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

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