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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047267
Receipt No. 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 2022/03/23

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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
Body fat percentage
Body weight
BMI
Waist circumference
Blood cholesterol
Blood pressure

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
Email 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
Email drc_shokuhin@drc-web.co.jp

Sponsor
Institute Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department

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
Email 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 Preinitiation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 03 Month 23 Day
Last modified on
2022 Year 03 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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