UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of beta-cryptoxanthin on students during pharmacy practice
Title of the study (Brief title)	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	Keiko Unno
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5731
Email	kendaiunno@gmail.com

Public contact
Name of contact person	Keiko Unno
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000019908