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

Not Applicable

Completed

• Conditions: Mildly Hypercholesterolemic Subjects
• Interventions: Other: 2- Low fat drinkable fermented dairy product without plant sterols (control); Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

• Registration Number: NCT01571869
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-12
• Study Completion: 2006-04
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2 = Control product	2- Low fat drinkable fermented dairy product without plant sterols (control)	-
1 = Tested product	1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit	-

Trial Locations

Locations (1)

McGill University; 🇨🇦 Ste-anne-de-bellevue, Quebec, Canada