Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

NCT01571882 | Completed

• 1 other identifier: NU235
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

Conditions

Mildly Hypercholesterolemic Subjects

Keywords

Plant sterol - Policosanols - Hypercholesterolemia - Dairy

Study Arms (3)

1 = Tested product 1

EXPERIMENTAL

Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit

2 = tested product 2

EXPERIMENTAL

Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit

3 = Active control product

ACTIVE COMPARATOR

Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)

Interventions

1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit OTHER

1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)

1 = Tested product 1

2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit OTHER

2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)

2 = tested product 2

3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control) OTHER

3- Intervention with active control product (1,6 g of plant sterol/ day)

3 = Active control product

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female aged 20-75 years;
• BMI between 19 and 30 kg/m2 ,
• LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months,
• without statin monotherapy or other hypocholesterolaemic drug treatment,
• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

You may not qualify if:

• serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Guildford Clinical Pharmacology Unit Ltd. (Gcpl)

Guildford, Surrey, GU2 7YG, United Kingdom

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: June 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

GB (1)