UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021775
Receipt No. 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 (Ver. 5)

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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
Email 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
Email unno@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025112