UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040736 |
|---|---|
| Receipt number | R000046505 |
| Scientific Title | A randomized, placebo, double-blind study on improving suppression of fat accumulation in healthy humans by test food |
| Date of disclosure of the study information | 2021/12/30 |
| Last modified on | 2021/11/27 13:37:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
se-koizumi@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
R&D center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046505
