UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006989 |
|---|---|
| Receipt number | R000008013 |
| Scientific Title | Effects of late-night snacking on energy metabolism in healthy women |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2019/08/20 17:39:17 |
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Basic information
Public title
Effects of late-night snacking on energy metabolism in healthy women
Acronym
Effects of late-night snacking on energy metabolism in healthy women
Scientific Title
Effects of late-night snacking on energy metabolism in healthy women
Scientific Title:Acronym
Effects of late-night snacking on energy metabolism in healthy women
Region
| Japan |
Condition
Condition
Healthy female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of a 2-week late night snacking intervention on energy metabolism compared with those of daytime snacking in healthy women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Energy expenditure and substrate utlization
Key secondary outcomes
Appetite, food intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Nighttime snacking (23:00)
Interventions/Control_2
Daytime snacking (10:00)
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
healthy not overweight/obese [body mass index (BMI) >=18 to <25]
usual eating pattern of 3 meals/d
menstrual cycle was regular or on the
oral contraceptive pills
no current pregnant or lactation
Key exclusion criteria
history or medication use of CVD, hypertension, diabetes, hypercholesterolaemia, hyperglycemia, hyperlipidemia and eating disorder
smoking
excessive alcohol intake
those with allergies to ingredients in the test food
weight change over 2.0 kg before two month before this trial
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun OKa |
Organization
Tokyo Kasei University
Division name
Department of Home Economics
Zip code
Address
1-18-1, Kaga Itabashi-ku Tokyo 173-8602 JAPAN
TEL
03-3961-8026
okajun@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanobu Hibi |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3, Bunka Sumida-ku TOKYO 131-8501 JAPAN
TEL
03-5630-7266
Homepage URL
hibi.masanobu@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
JAPAN
Other related organizations
Co-sponsor
Ochanomizu University
Name of secondary funder(s)
Ochanomizu University
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
| 2012 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
https://doi.org/10.1152/ajpregu.00115.2012
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1152/ajpregu.00115.2012
Number of participants that the trial has enrolled
11
Results
Relative to daytime snacking, nighttime snacking significantly decreased fat oxidation and tended to increase the respiratory quotient. The frequency of snack intake and energy intake, body weight, and energy expenditure were not affected. Total and low-density lipoprotein (LDL) cholesterol significantly increased after nighttime snacking, but glucose and insulin levels after the glucose load were not affected.
Results date posted
| 2019 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young woman
Participant flow
Thirteen healthy women participated, eleven women were analyzed.
Adverse events
none
Outcome measures
Energy metabolism, LDL cholesterol
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008013
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
