UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047267 |
|---|---|
| Receipt number | R000053511 |
| Scientific Title | Verification test of body fat reduction effect by ingesting test food |
| Date of disclosure of the study information | 2022/06/19 |
| Last modified on | 2024/03/22 16:05:23 |
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Basic information
Public title
Verification test of body fat reduction effect by ingesting test food
Acronym
Body fat reduction test by food intake
Scientific Title
Verification test of body fat reduction effect by ingesting test food
Scientific Title:Acronym
Body fat reduction test by food intake
Region
| Japan |
Condition
Condition
healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effect of reducing body fat by ingesting food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat 8 weeks,12 weeks after the start of food intake
Key secondary outcomes
8, 12 weeks after the start of feeding
Belly fat
Body weight
BMI
Waist circumference
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingest foods containing 100 mg of plant-derived extract for 12 weeks
Interventions/Control_2
Ingest foods containing 300 mg of plant-derived extract for 12 weeks
Interventions/Control_3
Inoculate placebo food 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Persons with a BMI of 23 kg /m2 or more and less than 30 kg / m2
(2) Obese people with a lot of body fat
(3) Persons who voluntarily consent to participate in the examination by writing
Key exclusion criteria
(1) Those who are currently judged to have dyslipidemia or hypertension and are undergoing some kind of treatment.
(2) Ingesting foods and health foods containing the ingredients involved in this test food (plant extract)person
(3) Health foods and dietary supplements related to cholesterol, blood pressure, blood lipids, and blood sugar levelsThose who use it regularly
(4) Glucose metabolism, lipid metabolism, liver disease, renal disease, cardiovascular disease, digestive disease, respiratory disease, blood Persons with serious diseases such as humoral diseases, autoimmune diseases, endocrine diseases, and metabolic diseases.Or a person who has a medical history
(5) Persons with a history of drug allergies or serious food allergies
(6) Persons who have had abnormal laboratory test values and were judged to have problems participating in the study
(7) Persons with illnesses who are currently undergoing hospital visits, treatment, use of medications / external medicines, and follow-up
(8) Those who were judged to be inappropriate as subjects based on the results of the subject background questionnaire.
(9) Those who participated in other clinical studies at the start of this study
(10) Those who are pregnant or plan to breastfeed during the study period
(11) Persons who are judged by the investigator (or the person in charge of conducting the examination) to be inappropriate for participating in the examination
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medicial Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Furusyo |
Organization
DRC Co., Ltd
Division name
Food Human Testing Division
Zip code
530-0044
Address
5F, 9th Tabuchi Building, Higashitenma 2-10-31, Kita-Ku, Osaka city
TEL
06-6882-1130
Homepage URL
drc_shokuhin@drc-web.co.jp
Sponsor or person
Institute
Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department
Personal name
Funding Source
Organization
Iwase Cosfa 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
Brain Care Clinic Ethics Review Committee
Address
Samon-Cho13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel
03-3351-3386
drc_shokuhin@drc-web.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 | 06 | Month | 19 | 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
| 2022 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053511
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