UMIN-CTR Clinical Trial

Public title

Effect of supplement on fatigue of adult males and females with feeling fatigue. -a randomized, double-blind, placebo-controlled study-

Acronym

Effect of supplement on fatigue of adult males and females with feeling fatigue.

Scientific Title

Effect of supplement on fatigue of adult males and females with feeling fatigue. -a randomized, double-blind, placebo-controlled study-

Scientific Title:Acronym

Effect of supplement on fatigue of adult males and females with feeling fatigue.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effect of ingestion of supplement on fatigue.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fatigue sensation (VAS)

Key secondary outcomes

POMS Japanese version
Blood concentration of MDA-LDL and CoQ10 oxidation rate

Study type

Interventional

Basic design

Parallel

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

Ingestion of supplement for eight weeks.

Interventions/Control_2

Ingestion of placebo for eight 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

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy Japanese males and females aged 30 to 60 years at that time of study participation agreement.
2)Subject who are feeling fatigue nearly every day.
3)Weekday workers (Monday to Friday or Monday to Saturday service).
4)Subjects who were evaluated "fatigue" >=50 and "vigor" <=50 of T score in subscale of POMS Japanese version.
5)Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing.
6)Subjects who were deemed appropriate to participate in the study by the investigator.

Key exclusion criteria

1)Subjects who are undergoing medication suffer from some sort of disease.
2)Subjects who are during pregnancy or lactation, and possibility of pregnancy during the study period.
3)Subjects who have alimentary allergy.
4)Subjects who have a intake habit of continued medicines, quasi-drugs, food with health claims (food for specified health use), health foods and supplements such currently or within the past three months, furthermore going to their intake during the study period.
5)Subjects who have previous history or present illness of cardiovascular disease, nephritis, hepatitis, pancreatitis, and so on.
6)Subjects who have previous history of serious disability of liver, kidney, heart, lung, blood, and so on.
7)Subjects who have comorbidity and previous history of digestive system.
8)Subjects who have diagnosis history or strongly suspected of insomnia, sleep apnea syndrome, depression and menopause.
9)Subjects who have diagnosis history of chronic fatigue syndrome or idiopathic chronic fatigue.
10)Subjects who systolic blood pressure is 140 mmHg or more, or diastolic blood pressure is greater than or equal to 90 mmHg at rest.
11)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day).
12)Subjects who are planning to travel abroad or more than three days and two -nights of travel during the study period.
13)Subjects who are a blood donation of more than 200 mL in the past one month, or more than 400 mL in the past three months.
14)Subjects who are participating in other clinical trial or three months has not elapsed after joining other clinical trials.
15)Subjects who were deemed inappropriate to participate in the study by the investigator.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Sugino

Organization

Soiken Inc.

Division name

Representative Director

Zip code

Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL

Email

sugino@soiken.com

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

医療法人弘正会ふくだ内科クリニック（大阪府）

Date of disclosure of the study information

2016

Year

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

2016

Year

08

Month

20

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

08

Month

29

Day

Last modified on

2017

Year

06

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027440