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

Mildly Hypercholesterolemic Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571869
• Other study ID #: NU142
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: December 6, 2016
• Start date: April 2005
• Est. completion date: April 2006

Study information

• Verified date: December 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hypercholesterolemia
• Mildly Hypercholesterolemic Subjects

Intervention

Other:
• 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)
• 2- Low fat drinkable fermented dairy product without plant sterols (control)
2 - Intervention with control product (morning and/or evening)

Locations

Country	Name	City	State
Canada	McGill University	Ste-anne-de-bellevue	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Canada,