Status:
COMPLETED
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Unilever R&D
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 lipop...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Plasma HDL cholesterol (Less than 50 mg/dL)
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01803594
Start Date
August 1 2012
End Date
March 13 2015
Last Update
September 30 2022
Active Locations (1)
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1
UC Davis, Ragle Human Nutrition Center
Davis, California, United States, 95616