- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521156
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
October 26, 2016 updated by: Danone Research
Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Munich, Germany, 80636
- Harrison Clinical Research Clinical Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 1 = Control product
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1 = Intervention 1 (1 test product/day)
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Experimental: 2 = Tested product
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2 = Intervention 2 (1 test product/day)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 26, 2012
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 30, 2012
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- NU312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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