UMIN-CTR Clinical Trial

Basic information
Public title	The effects of olfactory stimulation with foods on mood and body temperatures: a randomized cross-over trial.
Acronym	The effects of olfactory stimulation with foods on mood and body temperatures.
Scientific Title	The effects of olfactory stimulation with foods on mood and body temperatures: a randomized cross-over trial.
Scientific Title:Acronym	The effects of olfactory stimulation with 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 effects of olfactory stimulation with foods on mood and body temperatures in healthy young women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mood-related parameter
Key secondary outcomes	Body temperatures Autonomic nervous system parameters Awakening scores Gastric motility (electrogastrography) Appetite scores

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Olfactory stimulation using a liquid sample with normal concentration
Interventions/Control_2	Olfactory stimulation using a liquid sample with lower concentration
Interventions/Control_3	Olfactory stimulation using a liquid sample with higher concentration
Interventions/Control_4	Olfactory stimulation using mineral water
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) Allergy against foods and drinks using this examination 8) No alcohol tolerance 9) 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 Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Suntory Global Innovation Center Ltd.(The sample supplier)
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（兵庫県）(University of Hyogo, Hyogo)

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 02 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	Completed
Date of protocol fixation	2015 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 02 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=R000020599

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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