UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of supplement on fatigue of adult males and females with feeling fatigue. -a randomized, double-blind, placebo-controlled study-
Title of the study (Brief title)	Effect of supplement on fatigue of adult males and females with feeling fatigue.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Fatigue sensation (VAS)
Key secondary outcomes	POMS Japanese version Blood concentration of MDA-LDL and CoQ10 oxidation rate

Base
Study type	Interventional

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

Intervention
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

Eligibility
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	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027440