UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037836 |
|---|---|
| Receipt number | R000043139 |
| 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. |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2021/03/31 13:37:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
fcrac@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043139
