UMIN-CTR Clinical Trial

Public title

An open-label, uncontrolled exploratory study to investigate the efficacy assessment for function claims of Ripe Kumquats "Tama-Tama"

Acronym

The clinical trial for efficacy assessment of Ripe Kumquats "Tama-Tama"

Scientific Title

An open-label, uncontrolled exploratory study to investigate the efficacy assessment for function claims of Ripe Kumquats "Tama-Tama"

Scientific Title:Acronym

The clinical trial for efficacy assessment of Ripe Kumquats "Tama-Tama"

Region

Japan

Condition

The healthy adults who complain fatigue

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasuji Arimura

Organization

University of Miyazaki

Division name

Division of Data Management, Department of Social Medicine, Faculty of Medicine

Zip code

Address

Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan

TEL

0985-85-9403

Email

yasuji_arimura@med.miyazaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuji Arimura

Organization

University of Miyazaki

Division name

Division of Data Management, Department of Social Medicine, Faculty of Medicine

Zip code

Address

Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan

TEL

0985-85-9403

Homepage URL

Email

yasuji_arimura@med.miyazaki-u.ac.jp

Institute

University of Miyazaki

Institute

Department

Personal name

Organization

Miyazaki prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

宮崎大学医学部附属病院（宮崎県）

Date of disclosure of the study information

2016

Year

01

Month

08

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

11

Month

25

Day

Date of IRB

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

Other related information

Registered date

2016

Year

01

Month

07

Day

Last modified on

2018

Year

11

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023568