Healthy VolunteersNCT02278393
A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults
A study testing 1-Fermented Dairy Product with Phytosterols (test) in people with Healthy Volunteers, run by Danone Japan at 1 site in Japan.
Trial summary
Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 1-Fermented Dairy Product with Phytosterols (test)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2014to May 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be checked at the inclusion visit (V1) :
- II 01: Male/female subject, aged from 20 to 55 years (bounds included).
- II 02: Subject with body mass index (BMI) between 18.5 kg/m2 (bound included) and 30 kg/m2 (bound excluded).
- II 03: Subject with LDL-cholesterol plasma level under 140 mg/dL (3.6 mmol/L) (bound excluded).
- II 04: Subject with triglycerides under 200 mg/dL (2.3 mmol/L) (bound included).
- II 05: Non hypertensive subject defined with Systolic Blood Pressure (SBP) <140mmHg and Diastolic Blood Pressure (DBP) <90 mmHg.
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- II 06: Subject agreeing not to consume any supplements/excessive plant sterols and plant stanols in any form during the study period.
- II 07: If of childbearing potential, female subject must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
- Oral birth control pills (at least 1 full monthly cycle prior to study product administration);
- Intra-uterine device (IUD);
- Double barrier methods (such as condoms and spermicide); OR female subject must be postmenopausal for at least 12 months prior to trial entry or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral tubal ligation).
- II 08: Subject covered by social security or covered by similar system.
- II 09: 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.
- II 10: Subject having given written (dated and signed) inform consent to take part in the study.
- II 11: Asian subjects originating from Japan
- II12: Subject who is able to communicate well with the investigator and to comply with the requirements of the entire study.
- II13: Subject having a fridge at home for study products storage with sufficient capacity.
- To be checked at the randomization visit (V2):
- RI 01: Subject having followed the dietary recommendations over the wash-out period.
Who cannot join
- To be checked at the inclusion visit (V1):
- IE 01: Subject having experienced any cardiovascular event (cardiac infarction, angina attack, surgical or endoscopic coronary angioplasty, stroke, arterial disease, etc.).
- IE 02: Subject suffering from any serious or chronic liver, renal, cardiovascular, respiratory, endocrine or metabolic disorders.
- IE 03: Subject with gastro-intestinal disorders (such as diarrhoea, constipation, irritable bowel syndrome) or using laxatives.
- IE 04: Subject with diabetes Type I and Type II or Fasting Blood Sugar test (FBS) > 125 mg/dL at screening visit.
- IE 05: Subject with active liver disease or hepatic dysfunction as defined by elevations in liver enzymes: [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) > 3X the upper limit of normal (ULN).
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- IE 06: Subject with unexplained serum creatine phosphokinase (CPK) > 2X the upper limit of normal (ULN). Subject with a reason for CPK elevation may continue in inclusion process and have the measurement repeated prior to randomization; a repeat CPK > 2X ULN is exclusionary.
- IE 07: Subject with weight change (variation > 5%) within 6 months at least prior to inclusion.
- IE 08: Subject taking any hypocholesterolemic drugs or products (statins, ezetimibe, sequesterants, niacin, nicotinates, probucol, omega-3 fatty acids (EPA-DHA, ALA…), and fibrates).
- IE 09: Subjects having stopped their hypocholesterolemic drugs or products for less than 3 months
- IE 10: Subject with known lactose intolerance.
- IE 11: Subject with known allergy or hypersensitivity to plant sterols and to any component of the study product (milk protein for example).
- IE 12: Subjects having sitosterolemia.
- IE 13: Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks, or who plans to have one during the course of the study.
- IE 14: Subject receiving (currently or in the 4 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
- IE 15: Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study.
- IE 16 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 before the start of the present study.
- IE 17: Subject with heavy alcohol intake (> 60 g/day).
- IE 18: Subject taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits (e.g. hypolipemic, hypoglycaemic treatments).
- IE 19: For female subject: pregnant woman or woman planning to become pregnant during the study; breast-feeding woman.
- IE 20: For female subject: subject likely to change her contraceptive method or hormone replacement therapy during the study.
- IE 21: Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study (e.g. -products consumer) or could constitute a special risk for the subject.
- IE 22: Subject who is susceptible to not comply with dietary qualitative restriction during the study period.
- IE 23 Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention.
- IE 24: Subject expected to be living in the same home as a current participating subject and to concomitantly receive some study products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE SAFETY OF EXCESSIVE CONSUMPTION OF PLANT STEROL-ENRICHED FERMENTED DAIRY PRODUCT OVER A 4-WEEK PERIOD IN JAPANESE HEALTHY ADULTS
Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults
- Conditions
- Healthy Volunteers
- Being tested
- 1-Fermented Dairy Product with Phytosterols (test), 2-Fermented dairy Product with No Phytosterols (control)
- Keywords
- Japanese healthy volunteers, High LDL-C, dairy drinks, phytosterols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Fermented Dairy Product with Phytosterols (test)Other
1- 3 bottles of test product/day
2-Fermented dairy Product with No Phytosterols (control)Other
2-3 bottles of control product/day
| Study group | Role | What they receive |
|---|---|---|
| 1-Fermented Dairy Product with Phytosterols (test) | Active comparator | one arm active = 3 bottles of test product/day with 1,6g of phytosterols each Receives: Other: 1-Fermented Dairy Product with Phytosterols (test) |
| 2-Fermented dairy Product with No Phytosterols (control) | Placebo comparator | one arm control product= 3 bottles test productl/day with no Phytosterols Receives: Other: 2-Fermented dairy Product with No Phytosterols (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of subjects with at least one adverse event by study group
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Secondary outcomes (5)
Adverse Events
Number of adverse events by study group
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Vital signs
Descriptive statistics for systolic and diastolic blood pressure, heart rate and BMI
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Vital signs
To assess the change for systolic and diastolic blood pressure, heart rate and BMI
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Laboratory measurements
Descriptive statistics for Haematology parameters, liver/kidney/muscle function parameters, carbohydrate metabolism parameters, lipids, minerals, proteins and electrolytes
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Laboratory measurements
To assess the change for Haematology parameters, liver/kidney/muscle function parameters, carbohydrate metabolism parameters, lipids, minerals, proteins and electrolytes
Measured: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine MRINI, MD, PHD, Study director, Danone Research Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278393
- Sponsor's protocol ID
- NU360
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE SAFETY OF EXCESSIVE CONSUMPTION OF PLANT STEROL-ENRICHED FERMENTED DAIRY PRODUCT OVER A 4-WEEK PERIOD IN JAPANESE HEALTHY ADULTS
- ClinicalTrials.gov ID
- NCT02278393
- Acronym / sponsor ID
- NU360
- Conditions
- Healthy Volunteers
- Keywords
- Japanese healthy volunteers, High LDL-C, dairy drinks, phytosterols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Danone JapanIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Oct 2014 (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.
Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Fermented Dairy Product with Phytosterols (test) | Active comparator | Other: 1-Fermented Dairy Product with Phytosterols (test)one arm active = 3 bottles of test product/day with 1,6g of phytosterols each |
| 2-Fermented dairy Product with No Phytosterols (control) | Placebo comparator | Other: 2-Fermented dairy Product with No Phytosterols (control)one arm control product= 3 bottles test productl/day with no Phytosterols |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- To be checked at the inclusion visit (V1) :
- II 01: Male/female subject, aged from 20 to 55 years (bounds included).
- II 02: Subject with body mass index (BMI) between 18.5 kg/m2 (bound included) and 30 kg/m2 (bound excluded).
- II 03: Subject with LDL-cholesterol plasma level under 140 mg/dL (3.6 mmol/L) (bound excluded).
- II 04: Subject with triglycerides under 200 mg/dL (2.3 mmol/L) (bound included).
Key exclusion criteria (25 listed)
- To be checked at the inclusion visit (V1):
- IE 01: Subject having experienced any cardiovascular event (cardiac infarction, angina attack, surgical or endoscopic coronary angioplasty, stroke, arterial disease, etc.).
- IE 02: Subject suffering from any serious or chronic liver, renal, cardiovascular, respiratory, endocrine or metabolic disorders.
- IE 03: Subject with gastro-intestinal disorders (such as diarrhoea, constipation, irritable bowel syndrome) or using laxatives.
- IE 04: Subject with diabetes Type I and Type II or Fasting Blood Sugar test (FBS) > 125 mg/dL at screening visit.
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-Fermented Dairy Product with Phytosterols (test)1- 3 bottles of test product/day | Other | 1-Fermented Dairy Product with Phytosterols (test) |
| 2-Fermented dairy Product with No Phytosterols (control)2-3 bottles of control product/day | Other | 2-Fermented dairy Product with No Phytosterols (control) |
Primary outcome
Adverse Events
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Number of subjects with at least one adverse event by study group
5 secondary outcomes
Adverse Events
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Vital signs
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Vital signs
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Laboratory measurements
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
Laboratory measurements
Time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)
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 30 Oct 2014.
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Screening Protocol
Pain
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.
Christine MRINI, MD, PHD study director
Danone Research Life Sciences
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-Fermented Dairy Product with Phytosterols (test) in people with Healthy Volunteers, 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 19 inclusion and 25 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 30 Oct 2014. 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.
What does the primary outcome measure?
Adverse Events (time frame: From baseline to 6 weeks (4-week consumption + 2-week follow-up periods)). It is what the study was designed to measure, not a finding.
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 30 Oct 2014.