UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005485 |
|---|---|
| Receipt number | R000006375 |
| Scientific Title | A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE |
| Date of disclosure of the study information | 2011/04/22 |
| Last modified on | 2012/10/30 10:57:19 |
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Basic information
Public title
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE
Acronym
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE
Scientific Title
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE
Scientific Title:Acronym
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE
Region
| Japan |
Condition
Condition
hypercholestemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of excessive consumption of a plant sterol-enriched chocolate for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bloodchemistry, hematology and physical examination at 2-week, 4-week consumption and 2-week after consumption period
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Safety of 4-week excessive consumption compared to before consumption
Interventions/Control_2
Safety of 4-week excessive consumption compared to placebo control
Interventions/Control_3
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 serum level between 200 mg/dL to 240 mg/dL; and LDL cholesterol between 120 mg/dL to 160 mg/dL (with half of the subjects at entry)
2) Subject with total cholesterol serum level under 200 mg/dL, or LDL cholesterol plasma under 120 mg/dL (with half of the subjects at entry)
3) Subject with SBP<160 mmHg and DBP<100 mmHg, BMI from 19 to 30 kg/m2, FBS less or equal 125 mg/dL
4) Subject, aged from 20 to 65 years (bounds included)
5) 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 taking any hypocholesterolemic
treatment drugs
2) Subject currently involved in a clinical trial
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 of the start of the present study
4) For female subject: pregnancy or possibility of pregnancy, or intention to be pregnant during the study
5) For female subject: breast feeding
6) Subject presenting known allergy or history of hypersensitivity
7) Subject having sitosterolemia
8) Subject receiving treatment for serious
liver, renal, cardio-vascular, respiratory, endocrine, of metabolic disorders
9) Subject deemed unsuitable by the investigator
Target sample size
40
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
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
| 2011 | Year | 04 | Month | 22 | 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
| 2011 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
| 2011 | Year | 04 | Month | 22 | Day |
Last modified on
| 2012 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006375
