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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023781
Receipt No. R000027394
Scientific Title Study on effects of a cereal derived processed product on postprandial energy metabolism.
Date of disclosure of the study information 2016/09/04
Last modified on 2017/06/20

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Basic information
Public title Study on effects of a cereal derived processed product on postprandial energy metabolism.
Acronym Study on effects of a cereal derived processed product on postprandial energy metabolism.
Scientific Title Study on effects of a cereal derived processed product on postprandial energy metabolism.
Scientific Title:Acronym Study on effects of a cereal derived processed product on postprandial energy metabolism.
Region
Japan

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

Objectives
Narrative objectives1 To investigate effects of a cereal derived processed product on postprandial energy metabolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fat oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)
Key secondary outcomes Respiratory quotient, thermic effect of food(TEF), i. e., diet-induced thermogenesis(DIT), energy expenditure, and carbohydrate oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)

Base
Study type Interventional

Study design
Basic design Cross-over
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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

Interventions/Control_2 Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

Interventions/Control_3 Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

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
25 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1)Aged between 24 and 59.
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)Daily excessive alcohol intake.
(Amount of alcohol intake >= 23 g/day)
4)Allergy against test food.
5)Person who can't accept to be accessed their medical records.
6)Person who can't answer a questionnaire about life situation and physical condition.
7)Person who are expecting pregnancy or lactation period.
8)Person who can't accept to disclose menstrual cycle.
9)Person who are considered inappropriate by the investigator, project leader, or medical doctors.
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noriyasu Oota
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7828
Email oota.noriyasu@kao.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Junko Suzuki
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7687
Homepage URL
Email suzuki.junko1@kao.co.jp

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 花王株式会社生物科学研究所(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 04 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
We clarified efficacy of the cereal derived processed products on post prandial fat oxidation.
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
2016 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 Day
Last follow-up date
2017 Year 04 Month 06 Day
Date of closure to data entry
2017 Year 05 Month 15 Day
Date trial data considered complete
2017 Year 05 Month 15 Day
Date analysis concluded
2017 Year 06 Month 09 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027394

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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