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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029650
Receipt No. R000033878
Scientific Title Effect of fruit juice aroma on mental stress in young women
Date of disclosure of the study information 2017/10/23
Last modified on 2017/10/21

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Basic information
Public title Effect of fruit juice aroma on mental stress in young women
Acronym Effect of fruit juice aroma on mental stress
Scientific Title Effect of fruit juice aroma on mental stress in young women
Scientific Title:Acronym Effect of fruit juice aroma on mental stress
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify of effect fruit juice aroma on mental stress in young women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain waves
Key secondary outcomes Heart rate variability, Visual analog scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Fruit juice
Interventions/Control_2 Water
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
30 years-old >
Gender Female
Key inclusion criteria Healthy adults who are between 20 and 30 years of age
Subjects who sign an informed consent form to participate in the study
Key exclusion criteria Subjects with
1)the feel uncomfortable to smell aroma of food sample
2)pregnancy, possible pregnancy
3)smoking habit
4)unqualification for this trial by the investigator
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Ohta
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code
Address 5-7-1 Befu, Jonann-ku, Fukuoka, Japan
TEL 092-851-2531
Email hohta@nakamura-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Ohta
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code
Address 5-7-1 Befu, Jonann-ku, Fukuoka, Japan
TEL 092-851-2531
Homepage URL
Email hohta@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

Funding Source
Organization Nakamura Gakuen University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 23 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 21 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
2017 Year 10 Month 21 Day
Last modified on
2017 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033878

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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