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

NCT01571869 | Completed

• 1 other identifier: NU142
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Plant sterol - hypercholesterolemia - dairy - meal

Study Arms (2)

1 = Tested product

EXPERIMENTAL

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

2 = Control product

PLACEBO COMPARATOR

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

Interventions

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

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

1 = Tested product

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

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

2 = Control product

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

McGill University

Ste-anne-de-bellevue, Quebec, H9X 3V9, Canada

Location

MeSH Terms

Interventions

Phytosterols

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: April 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: April 1, 2006
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

CA (1)