Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
This study has been completed.
Sponsor:
Danone Spain
Collaborator:
DEPARTMENT OF INTERNAL MEDICINE. HOSPITAL DE SANT JOAN
Information provided by (Responsible Party):
Danone Research ( Danone Spain )
ClinicalTrials.gov Identifier:
NCT01600820
First received: May 15, 2012
Last updated: May 16, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia |
Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit Other: 3- Low fat drinkable fermented dairy product without plant sterols(control) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Danone Research:
| Enrollment: | 126 |
| Study Start Date: | February 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 = Tested product 1 |
Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
1 = Intervention 1 (1 test product/day)
|
| Experimental: 2 = tested product 2 |
Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit
2 = Intervention 2 (1 test product/day)
|
| Placebo Comparator: 3 = Control product |
Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)
3 = Intervention 3 (1 control product/day)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Danone Research ( Danone Spain ) |
| ClinicalTrials.gov Identifier: | NCT01600820 History of Changes |
| Other Study ID Numbers: | NU146 |
| Study First Received: | May 15, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Danone Research:
|
Plant sterol Hypercholesterolemia diet |
dairy LDL-C Mildly hypercholesterolemic subjects |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013