UMIN-CTR Clinical Trial

Public title

Verification study of anti-fatigue effect by ingestion of test beverage

Acronym

Verification study of anti-fatigue effect by ingestion of test beverage

Scientific Title

Verification study of anti-fatigue effect by ingestion of test beverage

Scientific Title:Acronym

Verification study of anti-fatigue effect by ingestion of test beverage

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of test beverage ingestion on fatigue

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fatigue index using questionnaires after 2-week ingestion of test beverage

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of test beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of placebo beverage for 2 weeks

Interventions/Control_2

Intake of placebo beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of test beverage for 2 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

Age-lower limit

50

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Female

Key inclusion criteria

(1) Females aged between 50 and 64 years old who feel fatigue
(2) Subjects who have received sufficient explanation about the purpose and content of the study, have the ability to consent, voluntarily volunteered to participate, and agreed to participate it by signing the written informed consent

Key exclusion criteria

(1) Subjects who have history of diabetes, liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease
(2) Subjects who are judged by the principal investigator to have abnormal electrocardiogram
(3) Subjects who have injuries or illnesses that interfere with ergometer exercise
(4) Subjects who are under medical treatment
(5) Subjects who are allergic to food and drugs
(6) Subjects who cannot avoid taking health foods (including Food for Specified Health Uses, and Foods with Function Claims) and designated quasi-drugs during the test period
(7) Subjects who are taking medication (including OTC and prescription drugs)
(8) Subjects who have excessive alcohol consumption, or not avoid consumption of alcohol from the day before the test until the end of the test
(9) Subjects who are planning to get pregnant after the day of informed consent or are currently pregnant and lactating
(10) Subjects who have participated or are planning to participate in other clinical studies during the current study
(11) Subjects who are judged ineligible at the discretion of the principal investigator

Target sample size

10

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

530-0044

Address

9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-6135-5200

Email

tterashima@miula.co.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code

530-0044

Address

4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Morinaga & Co.,Ltd.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miura Clinic, Medical Corporation Kanonkai IRB

Address

9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka

Tel

06-6135-5200

Email

tterashima@miula.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人花音会みうらクリニック（大阪府）

Date of disclosure of the study information

2020

Year

03

Month

09

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

10

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

Main results already published

Date of protocol fixation

2020

Year

02

Month

20

Day

Date of IRB

2020

Year

02

Month

20

Day

Anticipated trial start date

2020

Year

02

Month

21

Day

Last follow-up date

2020

Year

06

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

02

Month

26

Day

Last modified on

2020

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045172