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

• ClinicalTrials.gov Identifier: NCT01574482
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: November 25, 2016
• Sponsor: Danone Research
• Information provided by (Responsible Party): Danone Research

Study Description

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

Condition or disease	Intervention/treatment	Phase
Mildly Hypercholesterolemic Subjects	Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
• Study Start Date: January 2007
• Actual Primary Completion Date: April 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 = Tested product	Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; 1 = Intervention 1 (1 test product/day)
Placebo Comparator: 2 = Control product	Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters; 2 = Intervention 2 (1 control product/day)

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Italy

Ospedale Silvestrini

Perugia, Italy, 06129

Sponsors and Collaborators

Danone Research

More Information

• Responsible Party: Danone Research
• ClinicalTrials.gov Identifier: NCT01574482
• Other Study ID Numbers: NU216
• First Posted: April 10, 2012
• Last Update Posted: November 25, 2016
• Last Verified: November 2016

Keywords provided by Danone Research:

Plant sterol - Hypercholesterolemia - diet - dairy

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases