UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022485 |
|---|---|
| Receipt number | R000025529 |
| Scientific Title | Relationships between food-specific appetite fluctuations and energy balance in free-living female university students |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2023/06/02 09:20:33 |
* 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
Relationships between food-specific appetite fluctuations and energy balance in free-living female university students
Acronym
Study on food-specific appetite fluctuations
Scientific Title
Relationships between food-specific appetite fluctuations and energy balance in free-living female university students
Scientific Title:Acronym
Study on food-specific appetite fluctuations
Region
| Japan |
Condition
Condition
healthy female university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate daily changes in food-specific appetites and their association with subjective states and energy balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
self-report questionnaires about food-specific appetite filled out several times a day in 7-day free-living recording session
Key secondary outcomes
1) self-report questionnaires about general appetite, mood, and arousal filled out several times a day, 2) energy intake estimated from dietary records, and 3) energy expenditure estimated from physical activity records, in 7-day free-living recording session.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
7-day free-living 1) with no intervention, 2) with bicycle ergometer exercise at self-selected intensity (1 hour/day), and 3) with voluntary diet containing energy decreased by excessive expenditure in 2) exercise.
Interventions/Control_2
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
healthy young females
Key exclusion criteria
1) pregnancy
2) serious disorder
3) regular hospital visit and medication
4) subjects judged by the investigator to be ineligible for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamanaka |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7-57, Taishido, Setagaya-ku, Tokyo
TEL
03-3411-7403
kentaro@swu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamanaka |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7-57, Taishido, Setagaya-ku, Tokyo
TEL
03-3411-7403
Homepage URL
kentaro@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Showa Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Women's University
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
Tel
03-3411-7351
kenkyu@swu.ac.jp
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
昭和女子大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 27 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025529
