Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
This study has been completed.
Sponsor:
Danone Research
Collaborator:
GUILDFORD CLINICAL PHARMACOLOGY UNIT LTD. (GCPL)
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01571882
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mildly Hypercholesterolemic Subjects |
Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
| 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 |
Resource links provided by NLM:
Further study details as provided by Danone Research:
| Enrollment: | 72 |
| Study Start Date: | June 2007 |
| 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) + 10 mg of policosanols per unit
1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)
|
| Experimental: 2 = tested product 2 |
Other: 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)
|
| Active Comparator: 3 = Active control product |
Other: 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)
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Danone Research |
| ClinicalTrials.gov Identifier: | NCT01571882 History of Changes |
| Other Study ID Numbers: | NU235 |
| Study First Received: | April 3, 2012 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Danone Research:
|
Plant sterol - Policosanols - Hypercholesterolemia - Dairy |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Policosanol Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 16, 2013