UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019209 |
|---|---|
| Receipt number | R000022208 |
| Scientific Title | Effect of well-balanced diet on postprandial energy metabolism. -Analysis of meal sequence effect- |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2016/03/04 09:39:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of well-balanced diet on postprandial energy metabolism.
-Analysis of meal sequence effect-
Acronym
Effect of well-balanced diet on postprandial energy metabolism
Scientific Title
Effect of well-balanced diet on postprandial energy metabolism.
-Analysis of meal sequence effect-
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 examine
the comparative effects of an unbalanced diet and a well-balanced diet on postprandial energy metbolism in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thermic effect of food (TEF), i. e., diet-induced thermogenesis (DIT), energy expenditure, substrate oxidation, respiratory quotient until 6 hours later of the meal.
Key secondary outcomes
Body temperature until 6 hours later of the meal.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: unbalanced diet. Second meal: unbalanced diet.
Interventions/Control_2
First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: well-balanced diet. Second meal: unbalanced diet.
Interventions/Control_3
First ingestion of a test meal (approximately 630 kcal/meal), following second ingestion of a test meal (approximately 630 kcal/meal) after 4 hours of first ingestion.
First meal: unbalanced diet. Second meal: well-balanced diet.
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)Japanese male Age >=20 and <=59 years.
2)Body mass index >=18.5 kg/m2 and <25 kg/m2
3)Fasting blood glucose value <126 mg/dL
4)Fasting triglyceride value >=50 and <=149 mg/dL
5)Systolic blood pressure <=139 mmHg and diastolic blood pressure <=89 mmHg
6)Informed consent provided
7)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
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Shimotoyodome |
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
0285-68-7589
shimotoyodome.akira@kao.co.jp
Public contact
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
suzuki.junko1@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
花王株式会社栃木事業場生理機能棟（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 02 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 07 | 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
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022208
