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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003779
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Soiken Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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