UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022940 |
|---|---|
| Receipt number | R000026440 |
| Scientific Title | A study to evaluate the effect of decreasing cholesterol level by ingestion of botanical ingredient-containing foods. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2017/06/01 12:08:09 |
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Basic information
Public title
A study to evaluate the effect of decreasing cholesterol level by ingestion of botanical ingredient-containing foods.
Acronym
A study to evaluate the effect of decreasing cholesterol level by ingestion of botanical ingredient-containing foods.
Scientific Title
A study to evaluate the effect of decreasing cholesterol level by ingestion of botanical ingredient-containing foods.
Scientific Title:Acronym
A study to evaluate the effect of decreasing cholesterol level by ingestion of botanical ingredient-containing foods.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of decreasing LDL cholesterol level by ingestion of botanical ingredient-containing foods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL cholesterol level, 4, 8 and 12 weeks after investigation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Botanical ingredient-containing foods, 12 Weeks.
Interventions/Control_2
Botanical ingredient-non-containing foods, 12 Weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years of age or older
2) 120 mg/dL <= LDL cholesterol level <= 139 mg/dL or,
140 mg/dL <=LDL cholesterol level <= 159 mg/dL
3) BMI < 25 kg/m2
4) With no treatment.
5) Submitting the written informed consent before this study.
Key exclusion criteria
1) Females in pregnancy, lactation and scheduled pregnancy period.
2) Subjects who are attending other studies or attended other studies within past 4 weeks.
3) Subject who are receiving continuous medical treatment.
4) Subjects who are;
(a) With present heart disorder, liver disorder, or kidney disorder,
(b) With previous or present cardiac disorder,
(c) With diabetes mellitus, or
(d) With allergy to the study foods.
5) Subjects who are deemed to be unsuitable by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Nakamura |
Organization
Suntory Business Expert Limited
Division name
HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL
03-5579-1277
Junichi_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Obata |
Organization
Suntory Business Expert Limited
Division name
HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL
03-5579-1277
Homepage URL
Hidenori_Obata@suntory.co.jp
Sponsor or person
Institute
Suntory Business Expert Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2016 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026440
