HealthyNCT01629888
A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
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 Healthy and Mild Hypercholesterolemia, run by Danone Japan at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Mild 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
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Jun 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
- male/female subjects,
- aged 20-65 years old,
- triglycerides (TG) levels under 400 mg/dL,
- total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
- LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
- non diabetic and non hypertensive,
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- accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
- effective contraceptive methods used for female subjects,
- having given written consent to take part in the study
Who cannot join
- subjects with sitosterolemia,
- subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
- taking any hypocholesterolemic treatment,
- presenting known allergy or hypersensitivity to plant sterols,
- dairy products and lactose, subject with heavy alcohol intake (> 60g/day),
- receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
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- subjects receiving a transplant or under immunosuppressor treatment,
- receiving treatment for any serious pathology.
- for female subject:
- pregnancy,
- breast feeding or
- intention to be pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.
- Conditions
- Healthy, Mild 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, dairy
- 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).Other
1 = Intervention 1 (3 test products/day)
2- plain low-fat dairy fermented product (drinkable) without plant sterols-estersOther
2 = Intervention 2 (3 control products/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Experimental | Not described Receives: Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Control product | Placebo comparator | Not described Receives: Other: 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 posted28 Jun 2012 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 48 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
- NCT01629888
- Sponsor's protocol ID
- NU336
- Status last verified
- Oct 2016
- First submitted
- 26 Jun 2012
- Last updated
- 10 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
- ClinicalTrials.gov ID
- NCT01629888
- Acronym / sponsor ID
- NU336
- Conditions
- Healthy, Mild Hypercholesterolemia
- Keywords
- Plant sterol, Hypercholesterolemia, dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Danone JapanIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Jun 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 safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Experimental | Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). |
| 2 = Control product | Placebo comparator | Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male/female subjects,
- aged 20-65 years old,
- triglycerides (TG) levels under 400 mg/dL,
- total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
- LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
Key exclusion criteria (12 listed)
- subjects with sitosterolemia,
- subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
- taking any hypocholesterolemic treatment,
- presenting known allergy or hypersensitivity to plant sterols,
- dairy products and lactose, subject with heavy alcohol intake (> 60g/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 (3 test products/day) | Other | 1 = Tested product |
| 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters2 = Intervention 2 (3 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 10 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 Healthy and Mild Hypercholesterolemia, 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 12 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 10 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 10 Oct 2016.