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Dietary Supplement
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism (HDL Trial)
N/A
Waitlist Available
Led By Jennifer T Smilowitz, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 4 hours
Summary
This trial involves participants drinking a special milkshake containing krill oil, dairy fats, lutein, and niacin. The study focuses on people with low levels of HDL cholesterol. Researchers will measure how these ingredients affect cholesterol metabolism by analyzing blood and urine samples. Krill oil has been studied for its effects on blood lipids, including lowering triglycerides and potentially affecting cholesterol levels.
Eligible Conditions
- High cholesterol
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 4 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma lipoprotein profile
Secondary study objectives
Plasma HDL proteome
Red blood cell functionality
Urinary metabolomics
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: PC700, Krill Oil, and LuteinActive Control3 Interventions
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)
Group II: PC700, Krill Oil, Lutein, and NiacinActive Control4 Interventions
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)
Group III: Control ShakePlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,756,112 Total Patients Enrolled
Unilever R&DIndustry Sponsor
129 Previous Clinical Trials
34,432 Total Patients Enrolled
Jennifer T Smilowitz, PhDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
38 Total Patients Enrolled
J. Bruce German, PhDPrincipal InvestigatorUniversity of California, Davis
4 Previous Clinical Trials
82 Total Patients Enrolled