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Recruitment status Completed
Unique ID issued by UMIN UMIN000023821
Receipt No. R000027440
Scientific Title Effect of supplement on fatigue of adult males and females with feeling fatigue. -a randomized, double-blind, placebo-controlled study-
Date of disclosure of the study information 2016/08/30
Last modified on 2017/06/06

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Basic information
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.

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

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Dynamic allocation
Institution consideration

No. of arms 2
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Ingestion of supplement for eight weeks.
Interventions/Control_2 Ingestion of placebo for eight weeks.

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

Research contact person
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

Public contact
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

Institute Soiken Inc.

Funding Source
Organization FANCL Corporation
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 医療法人弘正会ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 06 Month 06 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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