UMIN-CTR Clinical Trial

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