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

Not Applicable

Completed

• Conditions: Mildly Hypercholesterolemic Subjects
• Interventions: Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters; Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

• Registration Number: NCT01574482
• Lead Sponsor: Danone Research

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 of daily consumption in mildly hypercholesterolemic people treated or not by statins

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Study First Submitted: 2012-04-07
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• male and female aged 20-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used

Exclusion Criteria

• Subject with plasma triglycerides (TG) levels > or = 350 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), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, 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 the evaluation of efficiency or safety of the product , pregnant and breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 = Control product	2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters	-
1 = Tested product	1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).	-

Trial Locations

Locations (1)

Ospedale Silvestrini; 🇮🇹 Perugia, Italy