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

September 28, 2022 updated by: University of California, Davis

Postprandial Modulation of HDL Metabolism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • UC Davis, Ragle Human Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Dairy phospholipids
PC700 manufactured by Fonterra
Dietary supplement: Nicotinic acid
Natures Way

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lipoprotein profile
Time Frame: 0, 2, 4 hour postprandial
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)
0, 2, 4 hour postprandial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Unilever R&D

Investigators

  • Principal Investigator: Jennifer T Smilowitz, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

January 2, 2013

Study Completion (Actual)

March 13, 2015

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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