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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017165
Receipt No. R000019908
Scientific Title Effect of beta-cryptoxanthin on students during pharmacy practice
Date of disclosure of the study information 2015/04/27
Last modified on 2018/03/17

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Basic information
Public title Effect of beta-cryptoxanthin on students during pharmacy practice
Acronym Anti-stress effect of beta-cryptoxanthin
Scientific Title Effect of beta-cryptoxanthin on students during pharmacy practice
Scientific Title:Acronym Anti-stress effect of beta-cryptoxanthin
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 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 10 days
Key secondary outcomes Physical condition, State-trait anxiety inventory (STAI) test, Sleeping time, 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
Interventions/Control_2 Placebo orange juice
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 Male and Female
Key inclusion criteria 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 20days.
Possible to check salivary amylase activity two times daily for 20 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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Unno
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka
TEL 054-264-5731
Email kendaiunno@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Unno
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka
TEL 054-264-5731
Homepage URL
Email kendaiunno@gmail.com

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization University of Shizuoka
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
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 静岡県立大学  University of Shizuoka

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Beta-cryptoxanthin (CRX) is a provitamin A and a potent antioxidant that is abundant in Satsuma mandarin orange, which is the most popular fruit in Japan. The anti-stress effect of CRX on humans was evaluated in fifth-year university students during both routine daily life at the university and at pharmacy practice. Salivary amylase activity (sAA) was measured as a marker of sympathetic nervous system activity. In the placebo-group, sAA in the evening (post-practice sAA) tended to be higher than sAA in the morning (pre-practice sAA) during both routine daily life at the university and during pharmacy practice. In the CRX-group, the increase of post-practice sAA was suppressed in females. These results suggested that CRX has an anti-stress effect, at least, in females.
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 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 27 Day
Last follow-up date
2015 Year 05 Month 30 Day
Date of closure to data entry
2016 Year 05 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 30 Day
Date analysis concluded
2016 Year 05 Month 30 Day

Other
Other related information YAKUGAKU ZASSHI 136(9), 1255-1262, 2016

Management information
Registered date
2015 Year 04 Month 17 Day
Last modified on
2018 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019908

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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