Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571869

Enrollment

Registered

2012-04-05

Start date

2005-04-30

Completion date

2006-04-30

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

Mildly Hypercholesterolemic Subjects

Keywords

Plant sterol - hypercholesterolemia - dairy - meal

Brief summary

The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.

Interventions

OTHER2- Low fat drinkable fermented dairy product without plant sterols (control)

2 - Intervention with control product (morning and/or evening)

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

1-Intervention with test product (morning, evening or snack)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* male and post-menopausal female aged 40-80 years; * BMI between 22 and 32 kg/m2, * Non-smoker, Stabilized LDL-c over 3.0 mmol/L, * Not taking any medication known to affect lipid metabolism for at least the previous 3 month period, * Agree to follow the dietary recommendations in the context of their hypercholesterolemia, * Have to give written consent to take part in the study

Exclusion criteria

* Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95\<SBP\>140 mmHg and/or 45\<DBP\>90 mmHg), * Previous history of symptomatic vascular disease, TG level \> 2,8 g/l, * History of metabolic or gastrointestinal disease with the exception of appendicectomy, * Consumption of large amounts of alcohol, * Having undergone general anesthesia in the month prior to pre-selection, * Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, * Having serious or acute disease likely to influence study results or involved in life time, * Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them, * Refusing to stop his/her consumption of enriched plant sterol trade products during the study, * In a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject, * For female subjects: likely to change her hormonal substitutive treatment, * Currently in an exclusion period following participation in another clinical trial.

Countries

Canada

Outcome results

None listed

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