UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label, uncontrolled exploratory study to investigate the efficacy assessment for function claims of Ripe Kumquats "Tama-Tama"
Title of the study (Brief title)	The clinical trial for efficacy assessment of Ripe Kumquats "Tama-Tama"
Region	Japan

Condition
Condition	The healthy adults who complain fatigue
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical benefits, such as immune activation, associated with four weeks daily ingestion of ripe kumquats "Tama-Tama" for the healthy adult with fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Natural killer cell activity at baseline, one week, four weeks and eight weeks after ingestion of ripe kumquats.
Key secondary outcomes	1. Efficacy: immune function, adrenal function, glycometabolism, lipid metabolism, bone metabolism, energy metabolism, oxidation stress, spiritual stress, fatigue related scales and health related QOL. 2. Adverse events. 3. Blood concentrations of beta-cryptoxanthin. (They are assessed at at baseline, one week, four weeks and eight weeks after ingestion of ripe kumquats except adverse events.)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Subjects take one Kumquat "Tama-Tama" per day for four weeks.
Interventions/Control_2
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	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 complain daily fatigue 3. Subjects who have no abnormality in clinical problems by screening tests. 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. Subjects who are less than one (10mm) by VAS scale relating to their fatigue. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. 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. 8. Subjects with irregular lifestyle, such as diet and sleep (shift workers, late-night workers, etc). 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. 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. 11. Pregnant or lactating women or women expect to be pregnant during this study. 12. Subjects who have cognitive disorder or who have possibility of the disorder. 13. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 14. 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	Division of Data Management, Department of Social Medicine, Faculty of Medicine
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9403
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Yasuji Arimura
Organization	University of Miyazaki
Division name	Division of Data Management, Department of Social Medicine, Faculty of Medicine
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9403
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)

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 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 25 Day
Anticipated trial start date	2015 Year 11 Month 25 Day
Last follow-up date	2016 Year 03 Month 22 Day
Date of closure to data entry	2016 Year 05 Month 11 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 01 Month 07 Day
Last modified on	2018 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023568