UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030501 |
|---|---|
| Receipt number | 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 | 2023/06/28 17:26:24 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 08 | Day |
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
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034778
