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

A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01600820

Enrollment

126

Registered

2012-05-17

Start date

2005-02-28

Completion date

2005-07-31

Last updated

2016-12-07

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

Conditions

Hypercholesterolemia

Keywords

Plant sterol, Hypercholesterolemia, diet, dairy, LDL-C, Mildly hypercholesterolemic subjects

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.

Interventions

OTHER1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

1 = Intervention 1 (1 test product/day)

OTHER2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

2 = Intervention 2 (1 test product/day)

OTHER3- Low fat drinkable fermented dairy product without plant sterols(control)

3 = Intervention 3 (1 control product/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Countries

Spain

Outcome results

None listed

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