UMIN-CTR Clinical Trial

Basic information
Public title	Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Acronym	Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Scientific Title	Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Scientific Title:Acronym	Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Region	Japan

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

Objectives
Narrative objectives1	To validate some kind of effect by the test-food intakes for twelve weeks on visceral fat area and gut microenvironment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area (impedance method)
Key secondary outcomes	1. Abdominal total fat area (impedance method) 2. Abdominal subcutaneous fat area (impedance method) 3. Abdominal circumference 4. Body weight 5. Body-mass index 6. Body fat percentage (impedance method) 7. Body fat quantity (impedance method) 8. Blood pressure 9. Adiponectin 10. Gut microbiota (amplicon sequencing analysis) 11. Short chain fatty acids and IgA in feces 12. Total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, glucose

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Consumption of the test food-1 twice a day for 12 weeks.
Interventions/Control_2	Consumption of the test food-2 twice a day for 12 weeks.
Interventions/Control_3	Consumption of the placebo food twice a day for 12 weeks.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent. (2) Subjects ranging in BMI from not less than 23.0 to less than 30.0 kg/m2. (3) Subjects who can take the test foods for meals twice a day. (4) Subjects who can receive the test foods twice a week. (5) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria	Subjects - - (1) with dieting (exercise, meal-control), or going on, (2) taking in affecting foods (obesity/gut/ immuno-regulation, not less than 3 times a week, (3) with excessive alcohol intake, (4) who have taken affecting medicines (allergic/gut/laxative/obesity/antibiotic regulation) within the last month before the test-food intakes, (5) with history of appendix removal, (6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent, (7) planning to change their present life style and dietary habit, (8) with extremely irregular dietary habit, (9) with the roomer planning to participate in this study, (10) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (11) with medical history of serious diseases, (12) with a continuous medical treatment, (13) with not less than 6.5 % HbA1c, (14) with not less than 126 mg/dL of hungry blood-sugar level, (15) with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, (16) with pregnancy, possibly one, or lactating, (17) with drug/food allergy (wheat, egg, milk), (18) being under the other clinical tests (medicine or health food), or took part in those within the last 4 weeks, or will join those after the consent, (19) who donated their blood components or blood (0.2 L) within the last month, (20) who donated his blood (0.4 L) within the last 3 months, (21) who donated her blood (0.4 L) within the last 4 months, (22) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (23) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (24) being determined as ineligible by the principal/sub investigator - - .
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	Nisshin Seifun Group Inc.
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-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	2022 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	2021 Year 07 Month 16 Day
Date of IRB	2021 Year 07 Month 09 Day
Anticipated trial start date	2021 Year 07 Month 22 Day
Last follow-up date	2021 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 19 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051225