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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036127
Receipt No. R000041158
Scientific Title Effect of food-derived powder ingestion on postprandial blood components.
Date of disclosure of the study information 2019/03/08
Last modified on 2019/07/19

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Basic information
Public title Effect of food-derived powder ingestion on postprandial blood components.
Acronym Effect of food-derived powder ingestion on postprandial blood components.
Scientific Title Effect of food-derived powder ingestion on postprandial blood components.
Scientific Title:Acronym Effect of food-derived powder ingestion on postprandial blood components.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effects of food-derived powder containing diets with control diet on postprandial blood components in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood component concentration of 30, 60, 120, 240 minutes after single ingestion of food-derived powder containing diets or control diet.
Key secondary outcomes Cognitive function, fatigue, body temperature, questionnaire, etc. after single ingestion of food-derived powder containing diets or control diet.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Control diet consumption > wash out (more than 5 days) > test diet A consumption > wash out (more than 5 days) > test diet B consumption > wash out (more than 5 days) > test diet C consumption
Interventions/Control_2 test diet A consumption > wash out (more than 5 days) > test diet B consumption > wash out (more than 5 days) > test diet C consumption > wash out (more than 5 days) > Control diet consumption
Interventions/Control_3 est diet B consumption > wash out (more than 5 days) > test diet C consumption > wash out (more than 5 days) > Control diet consumption > wash out (more than 5 days) > test diet A consumption
Interventions/Control_4 test diet C consumption > wash out (more than 5 days) > Control diet consumption > wash out (more than 5 days) > test diet A consumption > wash out (more than 5 days) > test diet B consumption
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
Key inclusion criteria 1) Subjects who are Japanese male.
Age >=20 and <=60 years.
2) Informed consent provided
3) Able to follow the instructions of the study team
Key exclusion criteria 1) Serious disorder
2)Regular hospital visit and medication intended to cure
3) Food allergy and suspected food allergy (Self-reported)
4)Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Misawa
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7828
Email misawa.koichi@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Yano
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7164
Homepage URL
Email yano.michiko@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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
Address
Tel
Email

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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 08 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
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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 19 Day
Date of IRB
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 07 Month 19 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 03 Month 08 Day
Last modified on
2019 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041158

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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