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

Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01574482

Enrollment

116

Registered

2012-04-10

Start date

2007-01-31

Completion date

2007-06-30

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mildly Hypercholesterolemic Subjects

Keywords

Plant sterol - Hypercholesterolemia - diet - dairy

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

Interventions

OTHER1- 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)

OTHER2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

2 = Intervention 2 (1 control product/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026