Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

Hypercholesterolemia Clinical Trial

Official title:

Naturalis Clinical Trial for a Novel Phytosterol Formulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478789
• Other study ID #: B2010:096
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: December 20, 2011
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Nuturalis S.A.
• Study type: Interventional

Clinical Trial 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.

Description:

Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• WD-PS intervention phase
2g/d of free plant sterol in 100g yogurt
• PS-Ester intervention phase
2g/d of free plant sterol in 100g yogurt
• placebo
100g/d yogurt with no added plant sterol

Locations

Country	Name	City	State
Canada	Richarson Centre for Funtional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid Profile		Change from Baseline in lipid profile at 4 weeks (end of the phase)	No