UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of blood concentrations of beta-cryptoxanthin associated with ingestion of Ripe Kumquats "Tama-Tama". : A randomization open-label, non-eating simultaneous control comparison group study.
Title of the study (Brief title)	The clinical trial for blood concentrations of beta-cryptoxanthin associated with ingestion of Ripe Kumquats "Tama-Tama"
Region	Japan

Condition
Condition	Healthy adults.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether blood concentrations of beta-cryptoxanthin is increased or not by continuous ingestion of of Ripe Kumquat "Tama-Tama" for seven days.
Basic objectives2	Others
Basic objectives -Others	Biokinetics of functional substance.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum concentrations of beta-cryptoxanthin on the first day, 3rd day, 5th day, 8th day and five weeks after ingestion of Ripe Kumquat "Tama-Tama".
Key secondary outcomes	1. Natural killer cell activity 2. Interleukin-6 values 3. Fatigue related scales 4. QOL scales(SF-36) 5. Adverse events. (These secondary outcomes are assessed on the first day, 3rd day, 5th day, 8th day and five weeks after ingestion of Ripe Kumquat "Tama-Tama" except adverse events.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects take five Ripe Kumquats "Tama-Tama" per day for seven days.
Interventions/Control_2	The subjects take ten Ripe Kumquats "Tama-Tama" per day for seven days.
Interventions/Control_3	The subjects don't take Ripe Kumquat "Tama-Tama" for seven days.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who have no abnormality in clinical problems by screening tests. 3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Pre- or post-menopausal women having obvious changes in physical condition. 4. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 5. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 6. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 7. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within four weeks or blood components within two weeks prior to this study. 9. Pregnant or lactating women or women expect to be pregnant during this study. 10. Subjects who have cognitive disorder or who have possibility of the disorder. 11. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size	12

Research contact person
Name of lead principal investigator	Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Homepage URL
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	University of Miyazaki
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	宮崎大学医学部附属病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 18 Day
Last follow-up date	2017 Year 04 Month 10 Day
Date of closure to data entry	2017 Year 05 Month 26 Day
Date trial data considered complete	2017 Year 05 Month 26 Day
Date analysis concluded	2018 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 16 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028623