UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003779 |
|---|---|
| Receipt number | R000004575 |
| Scientific Title | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK - Effectiveness and Long-term Safety Study - |
| Date of disclosure of the study information | 2010/06/18 |
| Last modified on | 2010/12/20 17:07:48 |
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Basic information
Public title
A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study -
Acronym
A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study -
Scientific Title
A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study -
Scientific Title:Acronym
A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study -
Region
| Japan |
Condition
Condition
hypercholestemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effect on cholesterol reduction and the safety under the consumption of yoghurt drink enriched with plant sterols for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bloodchemisty, hematology and physical examination after 4-week, 8-week and 12-week consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Effectiveness and safety after 12 weeks of test food consumption compared to before consumption
Interventions/Control_2
Effectiveness and safety of 12-week test food consumption compared to placebo control
Interventions/Control_3
Effectiveness and safety of 12-week high-dose test food consumption compared to low-dose test food consumption
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)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.
2) Subject, aged from 20 to 65 years (bounds included)
3) Subject with BMI between 19 - 30 kg/m2; (bounds included)
4) Subject with triglycerides under 400 mg/dL
5) Non diabetic subjects (BS<=125 mg/dL)
6) Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
7) Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subjects (according to Japan Atherosclerosis Society guidelines)
8) Subject agreeing not to consume any supplements/excessive plant sterols in any form during the study priod (from initial to final visit)
9) 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.
Key exclusion criteria
1) Subject currently involved in other clinical trial.
2) Subject taking any hypocholesterolemic treatment (statins, ezetimibe, niacin, omega-3 FA, fibrates)
3) 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 prior to the start of the present study.
4) For female subject: pregnancy or intention to be pregnant during the study.
5) For female subject: breast feeding.
6) Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
7) Subject having lactose intolerance.
8) Subject having sitosterolemia
9) Diabetic subject (Type I and type II)
10) Subject with heavy alcohol intake (>60 g/day)
11) Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
12) Subject receiving a transplant or under immunosuppressor treatment
13) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
14) Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angor pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
15) Subject deemed unsuitable by the investigator.
Target sample size
117
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kajimoto |
Organization
Senrichuo Ekimae Clinic
Division name
Director
Zip code
Address
Senri Life Science Center 3F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Soiken Inc.
Division name
Department of Clinical Evaluation System
Zip code
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Soiken Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 18 | Day |
Last modified on
| 2010 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004575
