UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation
Title of the study (Brief title)	The effect of multi-supplement intake on attenuating fatigue sensation
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the multi-supplement on attenuating fatigue in daily life : a randomized, double-blind, placebo-controlled, 2-way crossover study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analogue scale (VAS), Chalder Fatigue Scale
Key secondary outcomes	Advanced trail making test (ATMT), 10-second high power test, spectrum analysis a-a interval of accelerated plethysmography, POMS 2 Adult Short, OSA sleep inventory MA version, oxidative stress markers, safety evaluation

Base
Study type	Interventional

Study design
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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Test food (4 weeks) -> Washout (4 weeks) -> Intake of Placebo (4 weeks)
Interventions/Control_2	Intake of Placebo (4 weeks) -> Washout (4 weeks) -> Intake of Test food (4 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 males and females aged from 30 to 60 years (bounds included) 2) Subject whose total score of Chalder Fatigue Scale is 21 or more 3) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria	1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subject having the chronic fatigue syndrome (CFS), or subject deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3) Subject having food allergy (gelatin) 4) Subject having a medical history of chest pain or syncope 5) Subject having an abnormality in the electrocardiogram 6) Subject having a subjective symptom of low back pain, arthralgia or lumbar hernia, disease of lower limbs, palpitations 7) Subject who regularly takes medicine or quasi-drugs having the efficacy on recovery of fatigue or nutrition disorder at physical fatigue 8) Subject who regularly takes processed food containing ingredients known to attenuate fatigue sensation 9) Subject who regularly takes food containing large amounts of carotenoid 10) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 11) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 12) Female subject who is pregnant or lactating, or intending to become pregnant during the study 13) Subject deemed unsuitable by the investigator
Target sample size	20

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
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	R&D Division
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	FUJIFILM 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

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 18 Day
Anticipated trial start date	2016 Year 08 Month 27 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	Published
URL releasing results	https://www.mdpi.com/2072-6643/10/3/281/htm
Results
Other related information

Management information
Registered date	2016 Year 08 Month 25 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027359