UMIN-CTR Clinical Trial

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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