UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026179
Receipt number R000030081
Scientific Title The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama". :A randomization open-label, non-eating simultaneous control comparison group study.
Date of disclosure of the study information 2017/02/17
Last modified on 2018/01/09 23:09:37

* 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

The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
:A randomization open-label, non-eating simultaneous control comparison group study.

Acronym

The clinical trial for anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".

Scientific Title

The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
:A randomization open-label, non-eating simultaneous control comparison group study.

Scientific Title:Acronym

The clinical trial for anti-fatigue effect 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 the clinical benefits, such as anti-fatigue effect, associated with four weeks daily ingestion of ripe kumquats "Tama-Tama" for the healthy adult.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Total score of Chalder fatigue scale at first day, four weeks and eight weeks after ingestion of ripe kumquats.

Key secondary outcomes

1. VAS score
2. QOL scales (SF-36)
3. Symptom scores of upper respiratory tract infections(URTI)
4. Duration of illness, the number of days from the onset to the complete disappearance of URTI symptoms
5. Percentage of visiting physicians due to symptoms of URTI
6. Incidence rate of influenza
7. Restriction of daily activities
8. Adverse events

(VAS score and QOL scales are assessed on the first day, four weeks and eight weeks after ingestion of ripe kumquats "Tama-Tama".)


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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The subjects take Kumquat "Tama-Tama" five pieces per day for four weeks

Interventions/Control_2

The subjects don't take Kumquat "Tama-Tama" for four weeks.

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

35 years-old <=

Age-upper limit

55 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who are 35-55 years old at informed consent.
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 don't fill any item of self-reported health questionnaire.
2. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
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), alcohol dependency or drug dependency or who have possibility of these dependency.
8. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect 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 before this study.
12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.

Target sample size

56


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 or person

Institute

University of Miyazaki

Institute

Department

Personal name



Funding Source

Organization

Miyazaki Brand Promotion Headquarters

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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 01 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 15 Day

Last follow-up date

2017 Year 04 Month 23 Day

Date of closure to data entry


Date trial data considered complete

2017 Year 06 Month 13 Day

Date analysis concluded

2017 Year 11 Month 28 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 16 Day

Last modified on

2018 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030081


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name