UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of blood concentrations of beta-cryptoxanthin associated with long term ingestion of Ripe Kumquats "Tama-Tama". : A randomization open-label, non-eating simultaneous control comparison group study
Acronym	The clinical trial for blood concentrations of beta-cryptoxanthin associated with long term ingestion of Ripe Kumquats "Tama-Tama"
Scientific Title	The investigation of blood concentrations of beta-cryptoxanthin associated with long term ingestion of Ripe Kumquats "Tama-Tama". : A randomization open-label, non-eating simultaneous control comparison group study
Scientific Title:Acronym	The clinical trial for blood concentrations of beta-cryptoxanthin associated with long term 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 Ripe Kumquats "Tama-Tama" for four weeks.
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, 8th day, 29th day and eight weeks after ingestion of Ripe Kumquats "Tama-Tama".
Key secondary outcomes	1. Natural killer cell activity 2. Interleukin-6 values 3. Body Mass Index 4. Body composition (muscle mass, fat content, body fat percentage), visceral fat area 5. Concentration of salivary amylase 6. Fatigue related scales 7. QOL scales(SF-36) 8. Adverse events. (The secondary outcomes 1 to 5 are assessed on the first day, 8th day, 29th day and eight weeks after ingestion , and the outcomes 6 and 7 are assessed on the first day, 29th day and eight weeks after ingestion.)

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 four weeks.
Interventions/Control_2	The Subjects take ten Ripe Kumquats "Tama-Tama" per day for four weeks.
Interventions/Control_3	The subjects don't take Ripe Kumquat "Tama-Tama" for four weeks.
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	60 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 have less than 50mcg/dL blood concentration of beta-cryptoxanthin on screening tests day. 4. 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	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
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	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
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	Miyazaki Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	University of Miyazaki

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	宮崎大学医学部附属病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2017 Year 08 Month 14 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 25 Day
Last follow-up date	2018 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2019 Year 06 Month 18 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 15 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033259