UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043406
Receipt number 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 17:21:32

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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 or person

Institute

Iwase Cosfa Co.,LTD.

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

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

Value
https://center6.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