UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036127 |
|---|---|
| Receipt number | 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 | 2026/01/20 17:34:27 |
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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
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
yano.michiko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Completed
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
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041158
