UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, placebo, double-blind study on improving suppression of fat accumulation in healthy humans by test food
Acronym	A randomized, placebo, double-blind study on improving suppression of fat accumulation in healthy humans by test food
Scientific Title	A randomized, placebo, double-blind study on improving suppression of fat accumulation in healthy humans by test food
Scientific Title:Acronym	A randomized, placebo, double-blind study on improving suppression of fat accumulation in healthy humans by test food
Region	Japan

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

Objectives
Narrative objectives1	Confirmation of effectiveness of suppressing fat accumulation by ingesting test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area, body composition, waist circumference
Key secondary outcomes

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	Duration: 6 months. Test materials: Test food 1 Does: 5g per day.
Interventions/Control_2	Duration: 6 months. Test materials: Test food 2 Does: 5g per day.
Interventions/Control_3	Duration: 6 months. Test materials: Placebo food Does: 5g per day.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy subjects over 20 and less 70 years. 2. A healthy person who does not show any abnormality in the medical examination within one year from the start of the test 3. Those with an initial visceral fat area of 80 cm2 or more 4. Those who can maintain an intake rate of 80% or more for 6 months.
Key exclusion criteria	1. A person with a history of serious illness. 2. Those who have abnormal liver and renal function test values in the health examination. 3. Those who have impaired cardiopulmonary function. 4. People with food and drug allergies. 5. Those who have undergone gastrointestinal surgery. 6. A person who has a chronic or acute infectious disease at the discretion of the doctor. 7. Those who are participating in other clinical studies at the start of this study. 8. Those who play intense sports and those on a diet. 9. Pregnant person. 10. Any other person who is judged to be inappropriate by the person in charge of the examination or the person in charge of the examination.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Seiko Middle name Last name Koizumi
Organization	Nitta Gelatin Inc.
Division name	R&D center
Zip code	581-0024
Address	Futamata 2-22, Yao city, Osaka, Japan
TEL	072-948-8252
Email	se-koizumi@nitta-gelatin.co.jp

Public contact
Name of contact person	1st name Seiko Middle name Last name Koizumi
Organization	Nitta Gelatin Inc.
Division name	R&D center
Zip code	581-0024
Address	Futamata 2-22, Yao city, Osaka, Japan
TEL	072-948-8252
Homepage URL
Email	se-koizumi@nitta-gelatin.co.jp

Sponsor
Institute	Nitta Gelatin Inc. R&D center
Institute
Department

Funding Source
Organization	Nitta Gelatin Inc. R&D center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nitta Gelatin Ethics Review Committee
Address	Futamata 2-22, Yao city, Osaka, Japan
Tel	072-949-5386
Email	hi-tanaka@nitta-gelatin.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 12 Month 30 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	2020 Year 05 Month 08 Day
Date of IRB	2020 Year 05 Month 18 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2021 Year 05 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 06 Month 12 Day
Last modified on	2021 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046505