Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)

• ClinicalTrials.gov Identifier: NCT01574469
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: December 7, 2016
• Sponsor: Danone Research
• Information provided by (Responsible Party): Danone Research

Tracking Information

• First Submitted Date: April 7, 2012
• First Posted Date: April 10, 2012
• Last Update Posted Date: December 7, 2016
• Study Start Date: September 2004
• Actual Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
• Official Title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
• Brief Summary: The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
• Condition: Mildly Hypercholesterolemic Subjects

Intervention

• Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
  1 = Intervention 1 (2 test products / day)
• Other: 2-Low fat fermented dairy product (control)
  2 = Intervention 2 (2 control products/day)

Study Arms

• Active Comparator: 1 = Tested product
  Intervention: Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
• Placebo Comparator: 2 = Control product
  Intervention: Other: 2-Low fat fermented dairy product (control)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 6, 2016): 194
• Original Actual Enrollment (submitted: April 7, 2012): 242
• Actual Study Completion Date: August 2005
• Actual Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent

Exclusion Criteria:

• Subject with plasma triglycerides (TG) levels>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01574469
• Other Study ID Numbers: NU114
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Danone Research
• Study Sponsor: Danone Research
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Danone Research
• Verification Date: December 2016