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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021626
Receipt No. R000024943
Scientific Title Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Date of disclosure of the study information 2016/03/26
Last modified on 2019/03/08

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Basic information
Public title Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Acronym Effects of olfactory stimulation derived from foods on mood and body temperatures.
Scientific Title Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Scientific Title:Acronym Effects of olfactory stimulation derived from foods on mood and body temperatures.
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the changes in mood and body temperatures after olfactory stimulation with foods in young women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Awakening/sleepiness scores
- resting condition
- during olfactory stimulation
- immediately after stimulation
Key secondary outcomes Body temperatures
Warm sensation
Autonomic nervous system activities

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Olfactory stimulation using liquid with normal concentration -> Wash out -> Control (olfactory stimulation using mineral water)
- single administration
- 10 ml of sample
- 65-min stimulation
Interventions/Control_2 Control (olfactory stimulation using mineral water) -> Wash out -> Olfactory stimulation using liquid with normal concentration
- single administration
- 10 ml of sample
- 65-min stimulation
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 1) Japanese women
2) Age >=20 years, <25 years
3)Good health conditions determined by the health examination in April 2015
4) Less than 2 kg body weight change within the past one month
5) Having a regular menstrual cycles
6) Informed consent provided
Key exclusion criteria 1) Pregnancy, breast-feeding, or planning a pregnancy
2) Received the medical treatment for hypertension/diabetes/dyslipidemia/heart disease or gastric ulcer
3) During medication
4) Had the excessive fatigue or stress within one month
5) History of smoking
6) Difficulty to determine the smell due to otolaryngology diseases
7) No alcohol tolerance
8) Subjects judged by the project leader to be ineligible for other reasons
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narumi Nagai
Organization University of Hyogo
Division name School of Human Science and Environment
Zip code
Address 1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL +81-79-292-1515
Email nagai@shse.u-hyogo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Narumi Nagai
Organization University of Hyogo
Division name School of Human Science and Environment
Zip code
Address 1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL +81-79-292-1515
Homepage URL
Email nagai@shse.u-hyogo.ac.jp

Sponsor
Institute University of Hyogo
Institute
Department

Funding Source
Organization Suntory Grobal innovation Center Ltd. (the sample supplier)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Suntory Grobal innovation Center Ltd.
Name of secondary funder(s)

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 兵庫県立大学環境人間学部(兵庫県)(School of Human Science and Environment, University ofHhyogo, Hyogo-prefecture)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 26 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
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
2016 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 26 Day
Last follow-up date
2016 Year 05 Month 01 Day
Date of closure to data entry
2016 Year 10 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 26 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024943

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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