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

NCT01803594 | Completed

• 1 other identifier: 264254
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Plasma lipoprotein profile

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

  0, 2, 4 hour postprandial

Secondary Outcomes (3)

• Plasma HDL proteome

  0, 2, 4 hours postprandial

• Urinary metabolomics

  0, 2, 4 hours

• Red blood cell functionality

  0, 2, 4 hours postprandially

Study Arms (3)

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.

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)

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)

Dietary Supplement: Krill Oil; Dietary Supplement: Lutein; Dietary Supplement: Nicotinic acid; Dietary Supplement: Dairy phospholipids

Interventions

Krill Oil DIETARY_SUPPLEMENT

Neptune Krill Oil Gold

PC700, Krill Oil, Lutein, and Niacin; PC700, Krill Oil, and Lutein

Lutein DIETARY_SUPPLEMENT

Jarrow Formulas

PC700, Krill Oil, Lutein, and Niacin; PC700, Krill Oil, and Lutein

Nicotinic acid DIETARY_SUPPLEMENT

Natures Way

PC700, Krill Oil, Lutein, and Niacin

Dairy phospholipids DIETARY_SUPPLEMENT

PC700 manufactured by Fonterra

PC700, Krill Oil, Lutein, and Niacin; PC700, Krill Oil, and Lutein

Control OTHER

Control shake without dietary supplements

Control Shake

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• Unilever R&D: collaborator

Study Sites (1)

UC Davis, Ragle Human Nutrition Center

Davis, California, 95616, United States

Location

Related Publications (7)

• 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.

  PMID: 19713204 BACKGROUND

• 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.

  PMID: 21524510 BACKGROUND

• 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.

  PMID: 15531663 BACKGROUND

• 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.

  PMID: 12792657 BACKGROUND

• 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.

  PMID: 15656713 BACKGROUND

• 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.

  PMID: 15640510 BACKGROUND

• 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.

  PMID: 12947433 BACKGROUND

Related Links

• More information about the research is available on the UC Davis Foods for Health Institute's website

MeSH Terms

Conditions

Dyslipidemias

Interventions

Lutein; Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jennifer T Smilowitz, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• J. Bruce German, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: August 1, 2012
• Primary Completion: January 2, 2013
• Study Completion: March 13, 2015
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (1)