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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043406
Receipt No. R000049368
Scientific Title A Study on the Effects of a Test Food for Reducing Body Fat.
Date of disclosure of the study information 2021/05/10
Last modified on 2021/08/26

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Basic information
Public title A Study on the Effects of a Test Food for Reducing Body Fat.
Acronym A Study on the Effects of a Test Food for Reducing Body Fat.
Scientific Title A Study on the Effects of a Test Food for Reducing Body Fat.
Scientific Title:Acronym A Study on the Effects of a Test Food for Reducing Body Fat.
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of a test food for reducing body fat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body fat mass
Key secondary outcomes Height, Weight, BMI, Blood pressure, Pulse rate, Waist circumference, AST, ALT, gamma-GTP (gamma-GT), ALP, LDH (LD), T-BIL, Direct bilirubin, Indirect bilirubin, TP, ALB, BUN (UN), CRE, UA, T-Cho, LDL-Cho, HDL-Cho, TG, GLC (GLU), Na, Cl, K, HbA1c, WBC, RBC, Hb, Ht, PLT, Leukocyte image, Protein ( Qualitative), Sugar (qualitative), Occult blood reaction (qualitative) ,Adiponectin, Hepatitis virus test (HBs antigen, HCV antibody), Physical condition change, Dietary / Exercise survey

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of botanical ingredient-containing food for 12 weeks.
Interventions/Control_2
Interventions/Control_3
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) Men and women aged 20 to 64
(2) Persons with a BMI of 23 kg / m2 or more and less than 30 kg / m2
(3) Obese people with a lot of body fat
(4) Persons who voluntarily consent to participate in the examination by writing
Key exclusion criteria (1) Those who are currently being treated for dyslipidemia
(2) Those who are currently receiving drugs for dyslipidemia and hypertension
(3) Persons who are ingesting ingredient foods and health foods involved in this test food
(4) Those who regularly use supplements related to cholesterol, blood pressure, blood lipids, and blood sugar levels
(5) Persons with serious or mental disorders of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, immune system, nervous system. And those who have a medical history
(7) Those who have a disease under treatment or who have a history of serious illness requiring medication
(8) Those who may develop allergies related to the test
(9) Those who are judged to be inappropriate as subjects based on the results of the lifestyle-related questionnaire
(10) Those who participated in other clinical studies at the start of this study
(11) Those who are pregnant or plan to breastfeed during the study period
(12) Persons who are judged by the investigator (or the person in charge of conducting the study) to be inappropriate for participating in the study



Target sample size 10

Research contact person
Name of lead principal investigator
1st name Sumio
Middle name Dr.
Last name Kondo
Organization Medical Corporation Kenshokai
Division name Fukushima Healthcare Center
Zip code 553-0004
Address 2-12-13, Tamagawa Fukushima-ku, Osaka, Japan
TEL 06-6882-1130
Email s.kondo@drc-web.co.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Furusho
Organization DRC Co., Ltd.
Division name Product Testing Department
Zip code 530-0044
Address No.9 Tabuchi Bldg. 3F, 2-10-31 Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL 06-6882-1130
Homepage URL
Email furusyo@drc-web.co.jp

Sponsor
Institute Iwase Cosfa Co.,LTD.
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 yuyosei@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
2021 Year 05 Month 10 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 10
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 01 Month 29 Day
Date of IRB
2021 Year 01 Month 30 Day
Anticipated trial start date
2021 Year 01 Month 30 Day
Last follow-up date
2021 Year 04 Month 24 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 02 Month 22 Day
Last modified on
2021 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049368

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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