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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030501
Receipt No. R000034778
Scientific Title A clinical study to evaluate the anti-fatigue effect of S-allylcysteine
Date of disclosure of the study information 2019/04/30
Last modified on 2017/12/21

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Basic information
Public title A clinical study to evaluate the anti-fatigue effect of S-allylcysteine
Acronym A clinical study to evaluate the anti-fatigue effect of S-allylcysteine
Scientific Title A clinical study to evaluate the anti-fatigue effect of S-allylcysteine
Scientific Title:Acronym A clinical study to evaluate the anti-fatigue effect of S-allylcysteine
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the anti-fatigue effects of S-allylcysteine in a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fatigue sensation in visual analogue scale (VAS) after 2-week and 4-week intake of test food
Key secondary outcomes Performance test (10-second high power test) after 4-week intake of test food

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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake of test food for 4 weeks -> Washout for 4 weeks -> Intake of placebo for 4 weeks

Interventions/Control_2 Intake of placebo for 4 weeks -> Washout for 4 weeks -> Intake of test food for 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 people aged from 30 to 60 years
2) 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 a medical history of chest pain or syncope
4) Subject having an abnormality in the electrocardiogram
5) Subject having a subjective symptom of low back pain, joint pain or lumber hernia, disease of lower limbs, palpitations
6) Subject who has the possibility of developing allergic symptoms by the test food(gelatin allergy)
7)Subject who has a history of its physical condition getting worse after garlic intake
8)Subject who takes regularly health food containing an ingredient derived from garlic
9) Subject who takes regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue
10) Subject who takes regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
11) Subject who have a seasonal allergic rhinitis (cedar or Japanese cypress pollen) with moderate or severe symptoms
12) 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)
13) 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
14) Female subjects who is pregnant or lactating, or intending to become pregnant during the study
15) Subject deemed unsuitable by the investigator
Target sample size 24

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 Daicel 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
2019 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 23 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
2017 Year 12 Month 21 Day
Last modified on
2017 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034778

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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