Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)

Hypercholesterolemia Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600820
• Other study ID #: NU146
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: December 6, 2016
• Start date: February 2005
• Est. completion date: July 2005

Study information

• Verified date: December 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• male and female aged 18-75 years;

• BMI between 19 and 30 kg/m2 ,

• LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk = 20% without ischemic cardiopathy; or

• higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),

• with or without statin monotherapy,

• willing to respect the dietary advising delivered at the screening visit,

• agreeing to a written informed consent

Exclusion Criteria:

• subject with plasma triglycerides (TG) levels > 400 mg/dL,

• with any cardiovascular event in the last 6 months,

• subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,

• diabetic (type I and type II),

• presenting known allergy or hypersensitivity to milk proteins, soy or lactose,

• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,

• with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,

• pregnant or breast feeding women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
1 = Intervention 1 (1 test product/day)
• 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit
2 = Intervention 2 (1 test product/day)
• 3- Low fat drinkable fermented dairy product without plant sterols(control)
3 = Intervention 3 (1 control product/day)

Locations

Country	Name	City	State
Spain	Hospital de Sant Joan	Reus

Sponsors (1)

Lead Sponsor	Collaborator
Danone Spain

Country where clinical trial is conducted

Spain,