Mildly Hypercholesterolemic SubjectsNCT01574469
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
A study testing 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test) in people with Mildly Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mildly Hypercholesterolemic Subjects
- What is being tested?
- 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
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.
- Conditions
- Mildly Hypercholesterolemic Subjects
- Being tested
- 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test), 2-Low fat fermented dairy product (control)
- Keywords
- Plant sterol - Cholesterol absorption - diet - dairy - LDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
2-Low fat fermented dairy product (control)Other
2 = Intervention 2 (2 control products/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Active comparator | Not described Receives: 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 | Not described Receives: Other: 2-Low fat fermented dairy product (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2004
- Primary completionDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mildly Hypercholesterolemic SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574469
- Sponsor's protocol ID
- NU114
- Status last verified
- Dec 2016
- First submitted
- 7 Apr 2012
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01574469
- Acronym / sponsor ID
- NU114
- Conditions
- Mildly Hypercholesterolemic Subjects
- Keywords
- Plant sterol - Cholesterol absorption - diet - dairy - LDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1 = Tested product |
| 2-Low fat fermented dairy product (control)2 = Intervention 2 (2 control products/day) | Other | 2 = Control product |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test) in people with Mildly Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.