UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study for fat metabolism improving effect by single consumption of test beverage
Acronym	An evaluation study for fat metabolism improving effect by single consumption of test beverage
Scientific Title	An evaluation study for fat metabolism improving effect by single consumption of test beverage
Scientific Title:Acronym	An evaluation study for fat metabolism improving effect by single consumption of test beverage
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is evaluating for fat metabolism improving effect by single consumption of test beverage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Respiration quotient
Key secondary outcomes	Fat oxidation Energy expenditure Skin surface temperature of back Incidence of adverse events and of side effects

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test beverage just before measuring metabolism by exhalation - Measuring metabolism by exhalation. Rest period (over 5 days). Intake of control beverage just before measuring metabolism by exhalation - Measuring metabolism by exhalation.
Interventions/Control_2	Intake of control beverage just before measuring metabolism by exhalation - Measuring metabolism by exhalation. Rest period (over 5 days). Intake of test beverage just before measuring metabolism by exhalation - Measuring metabolism by exhalation.
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	40 years-old >
Gender	Male
Key inclusion criteria	1)Healthy males aged 20 to under 40 years old. 2) Males whose have no custom of exercise. 3) Males whose BMI ranges from 18.5 to 25.0 4) Males who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	1) Males who have previous and/or current medical history of serious disease (e.g., circulatory organs, respiratory organs, digestive organs, urinary organs and endocrine organs). 2) Males who constantly use or who can't restrict use oral medicines (related to blood pressure, fatigue and fat metabolism) having a possibility of affecting test results. 3) Males who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood pressure, blood flow, exercise fatigue, metabolic improvement, fat burning or lipolysis) having a possibility of affecting test results. 4) Males who excessive alcohol intake. 5) Male who may interfere with the operation of the test due to allergic rhinitis. 6) Males who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study. 7) Males who have smoking habit. 8) Males who are severe anemia 9) Males who have previous medical history of drug and/or food allergy. 10) Males who donated over 200mL blood and/or blood components within the last one month to this study. 11) Males who donated over 400mL blood and/or blood components within the last three months to this study. 12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 13) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ASAHI QUALITY & INNOVATIONS, 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 Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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	2021 Year 02 Month 06 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	40
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	2020 Year 01 Month 20 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 02 Month 07 Day
Last follow-up date	2020 Year 04 Month 30 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 02 Month 06 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044926