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

Mildly Hypercholesterolemic Subjects Clinical Trial

Official title:

Effects of the Consumption of a no Added Sugar Fermented Milk Product Enriched With Plant Sterols and Policosanols on Hypercholesterolaemia Management in Moderately Hypercholesterolaemic Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571882
• Other study ID #: NU235
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: November 23, 2016
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: November 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

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) + 10 mg of policosanols per unit
1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)
• 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit
2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)
• 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)
3- Intervention with active control product (1,6 g of plant sterol/ day)

Locations

Country	Name	City	State
United Kingdom	Guildford Clinical Pharmacology Unit Ltd. (Gcpl)	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

United Kingdom,