HypercholesterolemiaNCT01340287
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols
A study testing 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters in people with Hypercholesterolemia, run by Danone Global Research & Innovation Center at 1 site in United States.
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 of daily consumption in midly hypercholesterolemic people not treated by statins. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2009
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male/female subject,
- aged from 21 to 75 years,
- BMI between 19 and 30 kg/m2,
- LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
- stabilized hypercholesterolemia,
- accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
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- used to consume dairy products,
- effective contraceptive methods used for female subjects,
- having given written consent to take part in the study
Who cannot join
- subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
- having experienced any cardiovascular event in the last 6 months,
- taking any hypocholesterolemic treatment,
- diabetic subject (type I and type II),
- smoking strictly more than 10 cigarettes / day,
- heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),
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- presenting known allergy or hypersensitivity to milk proteins,
- known soy allergy,
- refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
- receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- receiving a transplant and under immunosuppressor treatment,
- currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
- 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,
- 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 or subject likely to change her contraceptive method during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
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 of daily consumption in midly hypercholesterolemic people not treated by statins.
- Conditions
- Hypercholesterolemia
- Being tested
- 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols)., 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
- Keywords
- Plant sterol, Hypercholesterolemia, diet, dairy, isoprostanes, Midly 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- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).Dietary supplement
1 = Intervention 1 (1 test product/day)
2- plain low-fat dairy fermented product (drinkable) without plant sterols-estersDietary supplement
2 = Intervention 2 (1 control product/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Active comparator | Not described Receives: Dietary Supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Control product | Sham comparator | Not described Receives: Dietary Supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startJul 2008
- Primary completionMay 2009
- Study completionAug 2009
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 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
- NCT01340287
- Sponsor's protocol ID
- NU281
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2011
- 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
- Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
- ClinicalTrials.gov ID
- NCT01340287
- Acronym / sponsor ID
- NU281
- Conditions
- Hypercholesterolemia
- Keywords
- Plant sterol, Hypercholesterolemia, diet, dairy, isoprostanes, Midly hypercholesterolemic subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Apr 2011 (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 of daily consumption in midly hypercholesterolemic people not treated by statins.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Active comparator | Dietary Supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Control product | Sham comparator | Dietary Supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male/female subject,
- aged from 21 to 75 years,
- BMI between 19 and 30 kg/m2,
- LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
- stabilized hypercholesterolemia,
Key exclusion criteria (15 listed)
- subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
- having experienced any cardiovascular event in the last 6 months,
- taking any hypocholesterolemic treatment,
- diabetic subject (type I and type II),
- smoking strictly more than 10 cigarettes / day,
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- plain 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) | Dietary supplement | 1 = Tested product |
| 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters2 = Intervention 2 (1 control product/day) | Dietary supplement | 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 27 Oct 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- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). and 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters in people with Hypercholesterolemia, run by Danone Global Research & Innovation Center at 1 site in United States.
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 9 inclusion and 15 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 United States. 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 27 Oct 2016.