UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021775 |
|---|---|
| Receipt number | R000025112 |
| Scientific Title | Effect of beta-cryptoxanthin on female students during pharmacy practice |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/09/05 18:07:14 |
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Basic information
Public title
Effect of beta-cryptoxanthin on female students during pharmacy practice
Acronym
Anti-stress effect of beta-cryptoxanthin in female
Scientific Title
Effect of beta-cryptoxanthin on female students during pharmacy practice
Scientific Title:Acronym
Anti-stress effect of beta-cryptoxanthin in female
Region
| Japan |
Condition
Condition
Stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to measure stress symptoms in female students during pharmacy practice and to evaluate the efficacy of Japanese mandarin orange juice containing beta-cryptoxanthin in suppressing chronic stress, by measuring the salivary amylase activity and subjective stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Alteration in salivary amylase activity in students during pharmacy practice for 6 days.
Key secondary outcomes
Physical condition, Sleeping time, State-trait anxiety inventory (STAI) test, replying to a questionnaire (subjective stress, achievement emotion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Japanese mandarin orange juice containing beta-cryptoxanthin (125 mL) for 13 days
Interventions/Control_2
Placebo orange juice (125 mL) for 13 days
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
| 22 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students of pharmaceutical sciences in the 5th grade, non-smoker.
Obtained written informed consent from the student before participation.
Possible to take a pack of Japanese mandarin orange juice (125 ml) for 13 days.
Possible to check salivary amylase activity two times daily for 6 days.
Key exclusion criteria
Taking tranquilizer(s)
Smoker
Allergy against orange
Diagnosed as inadequate to participate in the study by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Unno |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5731
unno@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Unno |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5731
Homepage URL
unno@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka, School of Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
静岡県立大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Biol. Pharm. Bull. 42 (8), 1402-1408 (2019)
Publication of results
Published
Result
URL related to results and publications
Biol. Pharm. Bull. 42 (8), 1402-1408 (2019)
Number of participants that the trial has enrolled
23
Results
Beta-cryptoxanthin (CRX) is abundant in Satsuma mandarin orange. The participants were randomly assigned to CRX-rich orange juice or placebo groups. Salivary a-amylase activity, a marker of sympathetic nervous system activity, was significantly higher in the evening than in the morning in the placebo-group during pharmacy practice, but not in the CRX-group. The dose-dependency of CRX was observed in mice. These results indicate that the ingestion of CRX is helpful to reduce stress.
Results date posted
| 2019 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average 22.4 y
Participant flow
Participants were randomly divided into two groups
Adverse events
No
Outcome measures
Alteration in salivary amylase activity in students during pharmacy practice for 6 days.
Physical condition, Sleeping time, State-trait anxiety inventory (STAI) test, replying to a questionnaire (subjective stress, achievement emotion)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025112
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