UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022749 |
|---|---|
| Receipt number | R000026210 |
| Scientific Title | Effect of well-balanced diet on postprandial energy metabolism.(Comparison with control diet have a similar menu construction) |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2016/12/19 09:41:59 |
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Basic information
Public title
Effect of well-balanced diet on postprandial energy metabolism.(Comparison with control diet have a similar menu construction)
Acronym
Effect of well-balanced diet on postprandial energy metabolism.
Scientific Title
Effect of well-balanced diet on postprandial energy metabolism.(Comparison with control diet have a similar menu construction)
Scientific Title:Acronym
Effect of well-balanced diet 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
The aim of this study is to compare the effects of well-balanced diet with control diet that have similar menu construction on postprandial energy metabolism in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy expenditure, substrate oxidation, respiratory quotient of 0.5, 1,1.5, 2, 3, 4 hours after single ingestion of well-balanced diet or control diet.
Key secondary outcomes
Body temperature of 0.5, 1, 1.5, 2, 3, 4 hours after single ingestion of well-balanced diet 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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of well-balanced diet.(approximately 650 kcal/meal) -> Washout more than 5days -> Single ingestion of control diet.(approximately 650 kcal/meal)
Interventions/Control_2
Single ingestion of control diet.(approximately 650 kcal/mea) -> Washout more than 5days -> Single ingestion of well-balanced diet.(approximately 650 kcal/meal)
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
Key inclusion criteria
1)Subjects who are Japanese male.
Age >=20 and <=59 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)Daily excessive alcohol intake
(Amount of alcohol intake >= 23 g/day)
4)Food allergy and suspected food allergy (Self-reported)
5)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 | Noriyasu Ota |
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
ota.noriyasu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Suzukamo |
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
suzukamo.chika@kao.co.jp
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
| 2016 | Year | 06 | Month | 20 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2016 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026210
