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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032321
Receipt No. 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

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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
Institute Kao Corporation
Institute
Department

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
URL(English) https://upload.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


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