HypercholesterolemiaNCT01600820
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
A study testing 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit and 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit in people with Hypercholesterolemia, run by Danone Spain at 1 site in Spain.
Trial summary
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects 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
- Hypercholesterolemia
- What is being tested?
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit and 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Jul 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 higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
- higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
- with or without statin monotherapy,
- willing to respect the dietary advising delivered at the screening visit,
- agreeing to a written informed consent
Who cannot join
- subject with plasma triglycerides (TG) levels > 400 mg/dL,
- with any cardiovascular event in the last 6 months,
- subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
- diabetic (type I and type II),
- presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
- receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
- pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.
- Conditions
- Hypercholesterolemia
- Being tested
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit, 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit, 3- Low fat drinkable fermented dairy product without plant sterols(control)
- Keywords
- Plant sterol, Hypercholesterolemia, diet, dairy, LDL-C, Mildly hypercholesterolemic subjects
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unitOther
1 = Intervention 1 (1 test product/day)
2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unitOther
2 = Intervention 2 (1 test product/day)
3- Low fat drinkable fermented dairy product without plant sterols(control)Other
3 = Intervention 3 (1 control product/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product 1 | Experimental | Not described Receives: Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit |
| 2 = tested product 2 | Experimental | Not described Receives: Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit |
| 3 = Control product | Placebo comparator | Not described Receives: Other: 3- Low fat drinkable fermented dairy product without plant sterols(control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startFeb 2005
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600820
- Sponsor's protocol ID
- NU146
- Status last verified
- Dec 2016
- First submitted
- 15 May 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
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects
- ClinicalTrials.gov ID
- NCT01600820
- Acronym / sponsor ID
- NU146
- Conditions
- Hypercholesterolemia
- Keywords
- Plant sterol, Hypercholesterolemia, diet, dairy, LDL-C, Mildly hypercholesterolemic subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Danone SpainIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 17 May 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 sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product 1 | Experimental | Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit |
| 2 = tested product 2 | Experimental | Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit |
| 3 = Control product | Placebo comparator | Other: 3- Low fat drinkable fermented dairy product without plant sterols(control) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male and female aged 18-75 years;
- BMI between 19 and 30 kg/m2 ,
- LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
- higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
- with or without statin monotherapy,
Key exclusion criteria (8 listed)
- subject with plasma triglycerides (TG) levels > 400 mg/dL,
- with any cardiovascular event in the last 6 months,
- subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
- diabetic (type I and type II),
- presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
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 drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit1 = Intervention 1 (1 test product/day) | Other | 1 = Tested product 1 |
| 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit2 = Intervention 2 (1 test product/day) | Other | 2 = tested product 2 |
| 3- Low fat drinkable fermented dairy product without plant sterols(control)3 = Intervention 3 (1 control product/day) | Other | 3 = 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.
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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 drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit and 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit in people with Hypercholesterolemia, run by Danone Spain at 1 site in Spain.
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 7 inclusion and 8 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 Spain. 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; AzTrials last refreshed its copy on 7 Nov 2026.