UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032321
Receipt number R000035696
Scientific Title The study of a long-term ingestion of a plant-deriverd processed product
Date of disclosure of the study information 2018/04/19
Last modified on 2019/12/26 16:35:42

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Basic information

Public title

The study of a long-term ingestion of a plant-deriverd processed product

Acronym

The study of a plant-derivered processed product

Scientific Title

The study of a long-term ingestion of a plant-deriverd processed product

Scientific Title:Acronym

The study of a plant-derivered processed product

Region

Japan


Condition

Condition

Nothing(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of a long-term ingestion of a plant-derived processed product

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

safety

Key secondary outcomes

Body weight, Body Mass Index


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

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Control food (product code;T-001)
1-year repeated consumption
Dose of 1 serving per day
Body weight measurement every 1 or 2 month

Interventions/Control_2

Test food (product code;S-001)
1-year repeated consumption
Dose of 1 serving per day
Body weight measurement every 1 or 2 month

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1, healthy adult aged from 20 to 60
2, get informed consent in written

Key exclusion criteria

1, difficult o participate the study due to
dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions
2, surgery for a disease or an injury 2 months prior to the study
3, treatment with medicine to improve glucose metabolism, fat metabolism, or blood presser
4, cat't maintain his/her habitual consumption of foods with health claim, supplement use or physical activity throughout the study periods including pre-treatment period.
5, experienced unpleasant feeling during blood drawing.
6, use of pacemaker, or metallic allergy and skin disease
7, weight change of 3kg and more within 1 month before the study
8, shift worker
9, allergies against any constituents in the test diet
10, potential to entry test of same test diet
11, disagree with explanation for study
12, judged to be inappropriate as subject by physician in charge

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shinichiro
Middle name
Last name Saito

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN

TEL

03-5630-7456

Email

saito.shinichiro@kao.com


Public contact

Name of contact person

1st name Nami
Middle name
Last name Yamanaka

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN

TEL

03-5630-7456

Homepage URL


Email

yamanaka.nami2@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kao Corporation

Address

2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.com


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

2018 Year 04 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

68

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

2018 Year 03 Month 15 Day

Date of IRB

2018 Year 03 Month 15 Day

Anticipated trial start date

2018 Year 04 Month 20 Day

Last follow-up date

2019 Year 05 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 19 Day

Last modified on

2019 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035696


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name