DyslipidemiaHDLNCT01803594
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
A study testing Krill Oil, Lutein and Nicotinic acid in people with Dyslipidemia, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Krill Oil, Lutein and Nicotinic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 13 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Plasma HDL cholesterol (Less than 50 mg/dL)
Who cannot join
- 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
Show all 26Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis, Ragle Human Nutrition Center
Davis, California, 95616
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidemia
- Being tested
- Krill Oil, Lutein, Nicotinic acid, Dairy phospholipids, Control
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill OilDietary supplement
Neptune Krill Oil Gold
LuteinDietary supplement
Jarrow Formulas
Nicotinic acidDietary supplement
Natures Way
Dairy phospholipidsDietary supplement
PC700 manufactured by Fonterra
ControlOther
Control shake without dietary supplements
| Study group | Role | What they receive |
|---|---|---|
| Control Shake | Placebo comparator | 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. Receives: Other: Control |
| PC700, Krill Oil, and Lutein | Active comparator | 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) Receives: Dietary Supplement: Krill Oil; Dietary Supplement: Lutein; Dietary Supplement: Dairy phospholipids |
| PC700, Krill Oil, Lutein, and Niacin | Active comparator | 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) Receives: Dietary Supplement: Krill Oil; Dietary Supplement: Lutein; Dietary Supplement: Nicotinic acid; Dietary Supplement: Dairy phospholipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipoprotein profile
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)
Measured: 0, 2, 4 hour postprandial
Secondary outcomes (3)
Plasma HDL proteome
HDL particles isolated by ultracentrifugation will be characterized for their proteomics profile measured by mass spectrometry.
Measured: 0, 2, 4 hours postprandial
Urinary metabolomics
Urinary metabolites will be measured by NMR spectroscopy.
Measured: 0, 2, 4 hours
Red blood cell functionality
Red blood cells isolated from whole blood will be measured for sheer stress using an in-vitro microfluidic assay.
Measured: 0, 2, 4 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startAug 2012
- Primary completion2 Jan 2013
- Study completion13 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Jennifer T Smilowitz, PhD, Principal investigator, University of California, DavisJ. Bruce German, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803594
- Sponsor's protocol ID
- 264254
- Acronym
- HDL
- Status last verified
- Sep 2022
- First submitted
- 28 Feb 2013
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19713204Snow 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.
PubMed 21524510Mozaffarian 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.
PubMed 15531663Tholstrup 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.
PubMed 12792657Bunea 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.
PubMed 15656713Ribaya-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.
PubMed 15640510Kiokias 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.
PubMed 12947433
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Modulation of HDL Metabolism
- ClinicalTrials.gov ID
- NCT01803594
- Acronym / sponsor ID
- HDL / 264254
- Conditions
- Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Aug 2012 (actual)
- Primary completion
- 2 Jan 2013 (actual)
- Study completion
- 13 Mar 2015 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Shake | Placebo comparator | Other: ControlEach 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. |
| PC700, Krill Oil, and Lutein | Active comparator | Dietary Supplement: Krill Oil, Dietary Supplement: Lutein, Dietary Supplement: Dairy phospholipidsEach 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) |
| PC700, Krill Oil, Lutein, and Niacin | Active comparator | Dietary Supplement: Krill Oil, Dietary Supplement: Lutein, Dietary Supplement: Nicotinic acid, Dietary Supplement: Dairy phospholipidsEach 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years
- Plasma HDL cholesterol (Less than 50 mg/dL)
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill OilNeptune Krill Oil Gold | Dietary supplement | PC700, Krill Oil, Lutein, and Niacin, PC700, Krill Oil, and Lutein |
| LuteinJarrow Formulas | Dietary supplement | PC700, Krill Oil, Lutein, and Niacin, PC700, Krill Oil, and Lutein |
| Nicotinic acidNatures Way | Dietary supplement | PC700, Krill Oil, Lutein, and Niacin |
| Dairy phospholipidsPC700 manufactured by Fonterra | Dietary supplement | PC700, Krill Oil, Lutein, and Niacin, PC700, Krill Oil, and Lutein |
| ControlControl shake without dietary supplements | Other | Control Shake |
Primary outcome
Plasma lipoprotein profile
Time frame: 0, 2, 4 hour postprandial
Plasma lipoprotein size distribution and concentration will be measured by nuclear magnetic resonance (NMR)
3 secondary outcomes
Plasma HDL proteome
Time frame: 0, 2, 4 hours postprandial
Urinary metabolomics
Time frame: 0, 2, 4 hours
Red blood cell functionality
Time frame: 0, 2, 4 hours postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 19713204Dalbeth 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.
- Background: PubMed 21524510Snow 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.
- Background: PubMed 15531663Mozaffarian 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.
- Background: PubMed 12792657Tholstrup 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.
- Background: PubMed 15656713Bunea 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.
- Background: PubMed 15640510Ribaya-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.
- Background: PubMed 12947433Kiokias 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.
- More information about the research is available on the UC Davis Foods for Health Institute's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer T Smilowitz, PhD principal investigator
University of California, Davis
J. Bruce German, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill Oil, Lutein and Nicotinic acid in people with Dyslipidemia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lipoprotein profile (time frame: 0, 2, 4 hour postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803594, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.