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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014