UMIN-CTR Clinical Trial

Basic information
Public title	Effect of 4-week continuous ingestion of Ripe Kumquats "Tama-Tama" on visceral fat area(VFA) reduction:A randomization open-label,non-eating control comparison group study.
Acronym	Clinical trial to investigate the effect of Ripe Kumquats"Tama-Tama" on VFA reduction
Scientific Title	Effect of 4-week continuous ingestion of Ripe Kumquats "Tama-Tama" on visceral fat area(VFA) reduction:A randomization open-label,non-eating control comparison group study.
Scientific Title:Acronym	Clinical trial to investigate the effect of Ripe Kumquats"Tama-Tama" on VFA reduction
Region	Japan

Condition
Condition	Healthy adults whose VFA is >=80cm2 and blood serum beta-cryptoxanthin<50 mcg/dL
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate of Ripe Kumquats "Tama-Tama" on VFA reduction.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change in VFA between pre-ingestion and at four weeks of ingestion of Ripe Kumquats "Tama-Tama".
Key secondary outcomes	1.The actual values and the change of VFA: at pre-ingestion and each evaluation points (4weeks and 8weeks ingestion of Ripe Kumquats "Tama-Tama"). 2.The actual values and the change of blood serum beta-cryptoxathin: at pre-ingestion and each evaluation points. 3.The actual values and the change of BMI, waist circumference and body composition analysis: at pre-ingestion and each evaluation points. 4.The actual values and the change of fatigue related scales:total score of Chalder fatigue scale, VAS scores, salivary amylase level: at pre-ingestion and each evaluation points. 5.The actual values and the change of Healthy QOL scales: at pre-ingestion and each evaluation points. 6.The actual values and the change of Natural killer cell activity level: at pre-ingestion and each evaluation points. 7.The actual values and the change of AGEs score: at pre-ingestion and each evaluation points. 8.The actual values and the change of glycolipid metabolism related index (HOMA-IR, glucose, insulin, HbA1C, triglyceride, free fatty acid level, HDL-cholesterol, LDL-cholesterol and uric acid) :at pre-ingestion and each evaluation points. 9.Adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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 Kumquats "Tama-Tama" per day 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 whose VFA>=80cm2 by screening test. 4.Subjects whose blood serum beta-cryptoxanthin<50mcg/dL by screening test. 5. 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 disease. 2.Subjects who have a serious injury or surgical history within 12weeks 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. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence. 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 donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study. 9. Subjects who are pregnant or lactating, or subjects who 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 four weeks prior to this study. 12.Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuji Middle name Last name Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code	889-1692
Address	Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Yasuji Middle name Last name Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code	889-1692
Address	Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL	0985-85-9577
Homepage URL
Email	fcrac@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)

IRB Contact (For public release)
Organization	Research Ethics Committee of University of Miyazaki
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel	0985-85-9010
Email	igakubu_kenkyu@med.miyazaki-u.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	宮崎大学医学部附属病院（宮崎県）University of Miyazaki hospital：Miyazaki prefecture

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 28 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	2019 Year 08 Month 08 Day
Date of IRB	2019 Year 08 Month 29 Day
Anticipated trial start date	2019 Year 08 Month 29 Day
Last follow-up date	2020 Year 03 Month 24 Day
Date of closure to data entry	2020 Year 05 Month 21 Day
Date trial data considered complete	2020 Year 10 Month 13 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 28 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043139