Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
Naturalis Clinical Trial for a Novel Phytosterol Formulation
1 other identifier
interventional
47
1 country
1
Brief Summary
The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 17, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedDecember 21, 2011
December 1, 2011
5 months
November 17, 2011
December 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Lipid Profile
Change from Baseline in lipid profile at 4 weeks (end of the phase)
Study Arms (3)
Water dispersible Plant Sterol (WD-PS)
EXPERIMENTALWD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol
Esterified plant sterol (PS-Ester)
EXPERIMENTALPS-Ester enriched dairy product (2g/d free plant sterol)
placebo
PLACEBO COMPARATOR100 g/d yogurt with no added plant sterol
Interventions
2g/d of free plant sterol in 100g yogurt
2g/d of free plant sterol in 100g yogurt
Eligibility Criteria
You may qualify if:
- healthy individuals aged 19-60 yr
- plasma LDL-C levels \> 3.0mmol/l
- TG \< 4.5mmol/l
- body mass index (BMI) between 20 and 30 kg/m2.
You may not qualify if:
- history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- history of chronic use of alcohol (\>2 drinks/d)
- smoking
- myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richarson Centre for Funtional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Richardson Centre for Functional Foods and Nutraceuticals
Study Record Dates
First Submitted
November 17, 2011
First Posted
November 23, 2011
Study Start
September 1, 2010
Primary Completion
February 1, 2011
Study Completion
October 1, 2011
Last Updated
December 21, 2011
Record last verified: 2011-12