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

NCT01574482 | Completed

• 1 other identifier: NU216
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Mildly Hypercholesterolemic Subjects

Keywords

Plant sterol - Hypercholesterolemia - diet - dairy

Study Arms (2)

1 = Tested product

EXPERIMENTAL

Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

2 = Control product

PLACEBO COMPARATOR

Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Interventions

1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). OTHER

1 = Intervention 1 (1 test product/day)

1 = Tested product

2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters OTHER

2 = Intervention 2 (1 control product/day)

2 = Control product

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Ospedale Silvestrini

Perugia, 06129, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2012
• First Posted: April 10, 2012
• Study Start: January 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

IT (1)