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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023757
Receipt No. R000027359
Scientific Title A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation
Date of disclosure of the study information 2018/05/14
Last modified on 2019/03/01

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Basic information
Public title A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation
Acronym The effect of multi-supplement intake on attenuating fatigue sensation
Scientific Title A study to evaluate the effect of multi-supplement intake on attenuating fatigue sensation
Scientific Title:Acronym 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
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
TEL 06-6645-6171
Email kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name R&D Division
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2072-6643/10/3/281/htm
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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 18 Day
Date of IRB
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

Other
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

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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