Mild Hypercholesterolemic SubjectsNCT01521156
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
A study testing 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols). in people with Mild Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Hypercholesterolemic Subjects
- What is being tested?
- 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Feb 2010
- 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/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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mild Hypercholesterolemic Subjects
- Being tested
- 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols)., 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).
- Keywords
- Plant sterols - Hypercholesterolemia - Diet - Dairy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).Other
1 = Intervention 1 (1 test product/day)
2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).Other
2 = Intervention 2 (1 test product/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Control product | Active comparator | Not described Receives: Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Tested product | Experimental | Not described Receives: Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 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
- NCT01521156
- Sponsor's protocol ID
- NU312
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2012
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols
- ClinicalTrials.gov ID
- NCT01521156
- Acronym / sponsor ID
- NU312
- Conditions
- Mild Hypercholesterolemic Subjects
- Keywords
- Plant sterols - Hypercholesterolemia - Diet - Dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 30 Jan 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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Control product | Active comparator | Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Tested product | Experimental | Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).1 = Intervention 1 (1 test product/day) | Other | 1 = Control product |
| 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) | Other | 2 = Tested 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 27 Oct 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 dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols). in people with Mild Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in Germany.
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 5 inclusion and 17 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 27 Oct 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 Germany. 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. 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 27 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.