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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022940
Receipt No. 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

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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
Email 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
Email Hidenori_Obata@suntory.co.jp

Sponsor
Institute Suntory Business Expert Limited
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026440

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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