Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)

NCT01600820 | Completed

• 1 other identifier: NU146
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.

Conditions

Hypercholesterolemia

Keywords

Plant sterol; Hypercholesterolemia; diet; dairy; LDL-C; Mildly hypercholesterolemic subjects

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) per unit

2 = tested product 2

EXPERIMENTAL

Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

3 = Control product

PLACEBO COMPARATOR

Other: 3- 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 1 (1 test product/day)

1 = Tested product 1

2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit OTHER

2 = Intervention 2 (1 test product/day)

2 = tested product 2

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

3 = Intervention 3 (1 control product/day)

3 = Control product

Eligibility Criteria

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

You may qualify if:

• male and female aged 18-75 years;
• BMI between 19 and 30 kg/m2 ,
• LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
• higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
• with or without statin monotherapy,
• willing to respect the dietary advising delivered at the screening visit,
• agreeing to a written informed consent

You may not qualify if:

• subject with plasma triglycerides (TG) levels \> 400 mg/dL,
• with any cardiovascular event in the last 6 months,
• subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
• diabetic (type I and type II),
• presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
• with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
• pregnant or breast feeding women

Sponsors & Collaborators

• Danone Spain: lead

Study Sites (1)

Hospital de Sant Joan

Reus, 43201, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: May 15, 2012
• First Posted: May 17, 2012
• Study Start: February 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

ES (1)