Normal and Mild Hypercholesterolemic SubjectsNCT01521169
Long-term Effectiveness Study on Cholesterol-reducing Activity
A study testing 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols)., 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols). and 3 - low-fat dairy fermented product (drinkable) without plant sterols. in people with Normal and Mild Hypercholesterolemic Subjects, run by Danone Japan at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal and Mild Hypercholesterolemic Subjects
- What is being tested?
- 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols)., 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols). and 3 - low-fat dairy fermented product (drinkable) without plant sterols.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Dec 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
- Subject aged from 20 to 65 years (bounds included)
- Subject with BMI between 19 - 30 kg/m² (bounds included)
- Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
- Non diabetic subjects (BS≤125 mg/dL)
- Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
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- Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
- Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study
Who cannot join
- Subject currently involved in a clinical trial.
- Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
- Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
- For female subject: pregnancy or intention to be pregnant during the study.
- For female subject: breast feeding.
- Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
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- Subject having lactose intolerance.
- Subjects having sitosterolemia
- Diabetic subject (Type I and type II)
- Subject with heavy alcohol intake (>60g/day)
- Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Subject receiving a transplant or under immunosuppressor treatment
- Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
- Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
- Subject deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Senrichuo Ekimae Clinic - Senri Life Science Center 13F
Osaka, 560-0082
About this study
Official title: Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study
The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.
- Being tested
- 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols)., 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols)., 3 - low-fat dairy fermented product (drinkable) without plant sterols.
- Keywords
- Plant sterol - 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 (0,8g /day equivalent as free sterols).Other
1 = Intervention with test product 1 (0,8g of plant sterol/day)
2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).Other
2 = Intervention with test product 2 (1,6g of plant sterol/day)
3 - low-fat dairy fermented product (drinkable) without plant sterols.Other
3 = Intervention 3 (1 control product/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product dose 1 | Active comparator | Not described Receives: Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols). |
| 2 = Tested product dose 2 | Active comparator | Not described Receives: Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols). |
| 3 = Control product | Sham comparator | Not described Receives: Other: 3 - low-fat dairy fermented product (drinkable) without plant 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 startFeb 2010
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal and 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521169
- Sponsor's protocol ID
- NU332
- 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
- Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study
- ClinicalTrials.gov ID
- NCT01521169
- Acronym / sponsor ID
- NU332
- Keywords
- Plant sterol - Hypercholesterolemia - Diet - Dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Danone JapanIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 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 effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product dose 1 | Active comparator | Other: 1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols). |
| 2 = Tested product dose 2 | Active comparator | Other: 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols). |
| 3 = Control product | Sham comparator | Other: 3 - low-fat dairy fermented product (drinkable) without plant sterols. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
- Subject aged from 20 to 65 years (bounds included)
- Subject with BMI between 19 - 30 kg/m² (bounds included)
- Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
- Non diabetic subjects (BS≤125 mg/dL)
Key exclusion criteria (15 listed)
- Subject currently involved in a clinical trial.
- Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
- Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
- For female subject: pregnancy or intention to be pregnant during the study.
- For female subject: breast feeding.
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 (0,8g /day equivalent as free sterols).1 = Intervention with test product 1 (0,8g of plant sterol/day) | Other | 1 = Tested product dose 1 |
| 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).2 = Intervention with test product 2 (1,6g of plant sterol/day) | Other | 2 = Tested product dose 2 |
| 3 - low-fat dairy fermented product (drinkable) without plant sterols.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 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 (0,8g /day equivalent as free sterols)., 2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols). and 3 - low-fat dairy fermented product (drinkable) without plant sterols. in people with Normal and Mild Hypercholesterolemic Subjects, run by Danone Japan at 1 site in Japan.
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 Japan. 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; AzTrials last refreshed its copy on 27 Oct 2026.