Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01521156
First received: January 26, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.


Condition Intervention
Mild Hypercholesterolemic Subjects
Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols

Resource links provided by NLM:


Further study details as provided by Danone Research:

Study Start Date: July 2009
Arms Assigned Interventions
Active Comparator: 1 = Control product Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (1 test product/day)
Experimental: 2 = Tested product Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).
2 = Intervention 2 (1 test 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/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
  • Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
  • Subject used to consume dairy products.
  • For female subjects: effective contraceptive methods used.
  • Subject having given written consent to take part in the study.

Exclusion Criteria:

  • Subject with blood triglycerides levels above 350 mg/dL.
  • Subject having experienced any cardiovascular event in the last 6 months.
  • Subject having sitosterolemia.
  • Subject taking any hypocholesterolemic treatment drugs.
  • Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
  • Diabetic subject (type I and type II).
  • Subject smoking strictly more than 10 cigarettes / day.
  • Subject with heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women).
  • Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
  • Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
  • Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
  • Subject receiving a transplant and under immunosuppressor treatment.
  • Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
  • Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
  • Subject with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product.
  • For female subject: pregnancy, breast feeding or intention to be pregnant during the study.
  • For female subject: subject likely to change her contraceptive method during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521156

Locations
Germany
Harrison Clinical Research Clinical Unit
Munich, Germany, 80636
Sponsors and Collaborators
Danone Research
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01521156     History of Changes
Other Study ID Numbers: NU312
Study First Received: January 26, 2012
Last Updated: January 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Danone Research:
Plant sterols - Hypercholesterolemia - Diet - Dairy

ClinicalTrials.gov processed this record on April 17, 2014