UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036840
Receipt number R000041970
Scientific Title Changes in body (size, blood etc.) due to intake of test article : a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2019/05/25
Last modified on 2020/04/13 10:17:10

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Basic information

Public title

Changes in body (size, blood etc.) due to intake of test article

Acronym

Trial of changes in body

Scientific Title

Changes in body (size, blood etc.) due to intake of test article : a randomized, double blind, placebo-controlled study

Scientific Title:Acronym

Trial of changes in body

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Intake test products for 8 weeks to assess body changes(size, blood etc.)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical measurement, blood test

Key secondary outcomes



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

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake test sample A for 8weeks

Interventions/Control_2

Intake test sample B for 8weeks

Interventions/Control_3

Intake placebo A for 8weeks

Interventions/Control_4

Intake placebo B for 8weeks

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

subjects who want to gain weight

Key exclusion criteria

1.Subjects with BMI 30 or more
2.Subjects with milk allergies
3.Subjects with food allergies
4.Subjects who are pregnant or lactating
5.Subject who wants to avoid weight gain and body size increase.
6.Subject on a diet
7.Subjects who consume medicinal product which may influence the outcome of the study
8.Subjects who consume food which may influence the outcome of the study
9. Subjects who are judged as unsuitable for the study by the investigator for the other reason

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Masatomo
Middle name
Last name Najima

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code

1600022

Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Email

info@yakujihou.org


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Kaneko

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code

1600022

Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Homepage URL


Email

info@yakujihou.org


Sponsor or person

Institute

Japan Clinical Trial Association

Institute

Department

Personal name



Funding Source

Organization

furusato wakando Inc.

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

Institutional Review Board of Pharmaceutical Law Wisdoms

Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

Tel

0364574911

Email

master@yakujihou.net


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

2019 Year 05 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

72

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

2019 Year 04 Month 18 Day

Date of IRB

2019 Year 04 Month 18 Day

Anticipated trial start date

2019 Year 05 Month 25 Day

Last follow-up date

2019 Year 07 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 24 Day

Last modified on

2020 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name