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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039805
Receipt No. R000045383
Scientific Title Examination of the effects of the test food intake on energy metabolism
Date of disclosure of the study information 2020/04/04
Last modified on 2020/03/12

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Basic information
Public title Examination of the effects of the test food intake on energy metabolism
Acronym Examination of the effects of the test food intake on energy metabolism
Scientific Title Examination of the effects of the test food intake on energy metabolism
Scientific Title:Acronym Examination of the effects of the test food intake on energy metabolism
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of single intake of test foods on energy expenditure, oxygen consumption, fat consumption, carbohydrate consumption and respiratory quotient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes energy expenditure
Key secondary outcomes oxygen consumption, fat consumption, carbohydrate consumption and respiratory quotient

Base
Study type Interventional

Study design
Basic design Cross-over
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 Intake of the test food before physical load -> washout period (1 week) -> Intake of the placebo before physical load
Interventions/Control_2 Intake of the placebo before physical load -> washout period (1 week) -> Intake of the test food before physical load
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
35 years-old >=
Gender Male
Key inclusion criteria 1) Males whose age of 20 to 35 years
2) BMI>=18.5 kg/m2 and <23.0 kg/m2
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
4) Subjects who can participate in the examination at the specified date and time
Key exclusion criteria 1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having a medical history of chest pain or syncope
3) Subjects having an abnormality in the electrocardiogram
4) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
5) Subjects who have the possibility of developing allergic symptoms by the test food
6) Subjects who take regularly Foods for Specified Health Uses, Foods with Function Claims labeled, medicines and quasi-drugs having the effect on energy metabolism
7) Subjects who have a smoking habit
8) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
9) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
10) Subjects deemed unsuitable by the investigator
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Susumu
Middle name
Last name Yoshino
Organization Maruzen Pharmaceuticals Co., Ltd
Division name Research & Development Division
Zip code 729-3102
Address 1089-8, Shinichi-cho Sagata, Fukuyama, Hiroshima
TEL 0847-52-5501
Email s-yoshino@maruzenpcy.co.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Sugino
Organization Soiken Inc.
Division name R&D Division
Zip code 560-0082
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals 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 Institutional Review Board of Fukuda Clinic
Address Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
Tel 06-6398-0203
Email fukudaclinicIRB@gmail.com

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
2020 Year 04 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 15 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2020 Year 04 Month 11 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045383

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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