UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028895 |
|---|---|
| Receipt number | R000033068 |
| Scientific Title | Effects of meal-to-meal change of nutrient composition on substrate utilization and appetite |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2017/08/30 06:01:45 |
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Basic information
Public title
Effects of meal-to-meal change of nutrient composition on substrate utilization and appetite
Acronym
Diurnal macronutrientchanges and energy metabolism
Scientific Title
Effects of meal-to-meal change of nutrient composition on substrate utilization and appetite
Scientific Title:Acronym
Diurnal macronutrientchanges and energy metabolism
Region
| Japan |
Condition
Condition
Obesity, Diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of diurnal macronutrient changes on substrate utilization, appetite, and blood glucose l
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy metabolism(energy expenditure, carbohydrate oxidation, fat oxidation)
Key secondary outcomes
Blood glucose, appetite
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
General macronutrient composition diet
Interventions/Control_2
High carbohydrate breakfast, high fat lunch, and high carbohydrate dinner
Interventions/Control_3
High fat breakfast, high carbohydrate lunch, and high carbohydrate dinner
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
No medical history related to diet, physical activity, sleep, metabolism, digestive, and circulation, no body weight change among past 6 months >+/-2kg, Body Mass Index <25 kg/m2, and body weight >55, <70.
Key exclusion criteria
medical history related to diet, physical activity, sleep, metabolism, digestive, and circulation, body weight change among past 6 month >+/-2kg, and Body Mass Index>25 kg/m2.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeho Tanaka |
Organization
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
Address
1-23-1 Toyama, Shinjuku, Tokyo
TEL
03-3203-5725
tanakas@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeho Tanaka |
Organization
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and
Division name
Department of Nutrition and Metabolism
Zip code
Address
1-23-1 Toyama, Shinjuku, Tokyo
TEL
03-3203-5725
Homepage URL
tanakas@nibiohn.go.jp
Sponsor or person
Institute
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 13 | 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
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2017 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033068
