UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052418 |
|---|---|
| Receipt number | R000059678 |
| Scientific Title | Effects of drinking fruit juice beverages on mental stress in young women |
| Date of disclosure of the study information | 2023/10/21 |
| Last modified on | 2023/10/05 09:48:08 |
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Basic information
Public title
Effects of drinking fruit juice beverages on mental stress in young women
Acronym
Effects of drinking fruit juice beverages on mental stress
Scientific Title
Effects of drinking fruit juice beverages on mental stress in young women
Scientific Title:Acronym
Effects of drinking fruit juice beverages 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 drinking fruit juice 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, Saliva amylase activity, 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 between the ages of 20 and 30
subjects who sign an informed consent form to participate in the study
Key exclusion criteria
Subjects with
1) the feel uncomfortable to drink food sample
2) pregnancy, possible pregnancy
3) smoking habit
4) unqualification for this trial by the investigation
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamoto |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
8140198
Address
5-7-1, Befu, Jounan-ku,Fukuoka, Japan
TEL
092-851-2531
yamaken@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamoto |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
8140198
Address
5-7-1, Befu, Jounan-ku,Fukuoka, Japan
TEL
092-851-2531
Homepage URL
yamaken@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University
Address
5-7-1, Befu, Jounan-ku,Fukuoka, Japan
Tel
092-851-5579
kks@nakamura-u.ac.jp
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
| 2023 | Year | 10 | Month | 21 | 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
| 2023 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059678
