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

NCT ID: NCT01571869

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-04-30

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.

Conditions

Mildly Hypercholesterolemic Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

1 = Tested product

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

2 = Control product

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

1- 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)

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

McGill University

Ste-anne-de-bellevue, Quebec, Canada

Countries

Canada

Other Identifiers

NU142

Identifier Type: -

Identifier Source: org_study_id