UMIN-CTR Clinical Trial

Basic information
Public title	Study for confirming anti-obesity effect by ingesting test food (preliminary examination)
Acronym	Study for confirming anti-obesity effect by ingesting test food (preliminary examination)
Scientific Title	Study for confirming anti-obesity effect by ingesting test food (preliminary examination)
Scientific Title:Acronym	Study for confirming anti-obesity effect by ingesting test food (preliminary examination)
Region	Japan

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

Objectives
Narrative objectives1	Confirmation of anti-obesity effect by ingesting test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight BMI Body fat percentage Visceral fat area
Key secondary outcomes	Amount of liver fat Fatty liver Waist circumference Incidence of adverse events and/or 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	Intake test foods for 12 weeks.
Interventions/Control_2	Intake control foods for 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	59 years-old >=
Gender	Male
Key inclusion criteria	(1) Males aged 20 to 59 when informed consent. (2) Subjects whose body mass index (BMI) is included between 23.0 kg/m^2 to less than 30.0 kg/m^2. (3) Subjects giving written informed consent.
Key exclusion criteria	(1) Subjects who are given continuous treatment by taking medicines. (2) Subjects who having Food for Specified Health Uses (FOSHU), functional food, health food and/or supplements having a possibility of affecting test results. (3) Subjects who have weak digestive organ. Especially subjects who may feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee. (4) Subjects who are severe anemia, or who have been diagnosed with severe anemia by the doctor (5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6) Subjects who excessive alcohol intake. (7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (8) Subjects who have previous medical history of drug and/or food allergy. (9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (12) Subjects 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 CO., LTD.
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwa-Uchikanda 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 Masanori Middle name Last name Numa
Organization	CPCC CO., LTD.
Division name	Plan Sales Department
Zip code	101-0047
Address	4F Sanwa-Uchikanda 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 CO., LTD.
Institute
Department

Funding Source
Organization	NAGAOKA 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 Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchikanda 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	2020 Year 07 Month 22 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	2019 Year 07 Month 19 Day
Date of IRB	2019 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 07 Month 22 Day
Last follow-up date	2019 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 19 Day
Last modified on	2020 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042668