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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit; Other: 3- Low fat drinkable fermented dairy product without plant sterols(control); Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

• Registration Number: NCT01600820
• Lead Sponsor: Danone Spain

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 = Tested product 1	1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit	-
3 = Control product	3- Low fat drinkable fermented dairy product without plant sterols(control)	-
2 = tested product 2	2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit	-

Trial Locations

Locations (1)

Hospital de Sant Joan; 🇪🇸 Reus, Spain