UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006989
Receipt No. 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 (Ver. 7)

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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
Email 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
Email hibi.masanobu@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008013