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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024498
Receipt No. R000028195
Scientific Title A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract
Date of disclosure of the study information 2017/10/21
Last modified on 2017/03/09

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Basic information
Public title A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract
Acronym An effect study of plant extract on human basal metabolism
Scientific Title A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract
Scientific Title:Acronym An effect study of plant extract on human basal metabolism
Region
Japan

Condition
Condition Healthy male adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of consumption of the food which contains plant extract on human basal metabolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Basal metabolic rate
Key secondary outcomes 1)Amount of visceral fat
2)Heart rate
3)Deep body temperature
4)Amount of activity
5)The incidence of adverse events and side effects

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 Prevention
Type of intervention
Food
Interventions/Control_1 Tablet candy which contains plant extract, 1 tablet in a day, 4 weeks.
Interventions/Control_2 Tablet candy which dose not contain plant extract, 1 tablet in a day, 4 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
49 years-old >=
Gender Male
Key inclusion criteria 1) Healthy males aged 20 to 49 years old.
2)Subjects whose body mass index (BMI) is 20 kg/m2 to 29.9kg/m2
3) Subjects whose visceral fat area is less than 100cm2
4) Subjects giving written informed consent.
Key exclusion criteria 1) Subjects who have severe disease in liver, kidney, heart, lung, digestive organ, blood, endocrine system and metabolic system.
2) Subjects who are currently receiving treatment or medication.
3) Subjects who have a history of allergic reaction or hypersensitivity to drug medicine and food.
4) Subjects who have a smoking habit.
5) Subjects who drink alcohol a lot.
6) Subjects who cannot participate the clinical test twice with 2 nights and 3 days.
7) Subjects who are participating the other clinical tests. Subjects who participated within 1 month prior to the current study and/or who plan to participate the other clinical tests.
8) Subjects who have midnight work or irregular shift work.
9) Subjects who have been judged as unsuitable for the study by the principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Planning and Sales Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization MORISHITA JINTAN CO.,LTD.
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 チヨダパラメディカルケアクリニック(東京都)
富士医科産業株式会社テクニカルセンター(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 21 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 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 22 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 10 Month 20 Day
Last modified on
2017 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028195

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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