NCT01574469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

April 7, 2012

Last Update Submit

December 6, 2016

Conditions

Mildly Hypercholesterolemic Subjects

Keywords

Plant sterol - Cholesterol absorption - diet - dairy - LDL

Study Arms (2)

1 = Tested product

ACTIVE COMPARATOR
Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

2 = Control product

PLACEBO COMPARATOR
Other: 2-Low fat fermented dairy product (control)

Interventions

1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)OTHER

1 = Intervention 1 (2 test products / day)

1 = Tested product
2-Low fat fermented dairy product (control)OTHER

2 = Intervention 2 (2 control products/day)

2 = Control product

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2012

First Posted

April 10, 2012

Study Start

September 1, 2004

Primary Completion

December 1, 2004

Study Completion

August 1, 2005

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

FR(1)