UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040273 |
|---|---|
| Receipt number | R000045937 |
| Scientific Title | Effects of oral 6-methylsulfinyl hexyl isothiocyanate ingestion on muscle damage after eccentric exercise in healthy males: a pilot placebo-controlled double-blind crossover study |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2020/04/30 01:01:26 |
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Basic information
Public title
Effects of oral 6-methylsulfinyl hexyl isothiocyanate ingestion on muscle damage after eccentric exercise in healthy males: a pilot placebo-controlled double-blind crossover study
Acronym
Effects of oral 6-methylsulfinyl hexyl isothiocyanate ingestion on muscle damage after eccentric exercise in healthy males: a pilot placebo-controlled double-blind crossover study
Scientific Title
Effects of oral 6-methylsulfinyl hexyl isothiocyanate ingestion on muscle damage after eccentric exercise in healthy males: a pilot placebo-controlled double-blind crossover study
Scientific Title:Acronym
Effects of oral 6-methylsulfinyl hexyl isothiocyanate ingestion on muscle damage after eccentric exercise in healthy males: a pilot placebo-controlled double-blind crossover study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether oral 6-methylsulfinyl hexyl isothiocyanate (6-MSITC) ingestion would inhibit elevations in plasma calpain-1 concentration and muscle strength e loss associated with intense upper arm eccentric exercise in health young males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal voluntary isometric contraction torque before and after eccentric exercise
Key secondary outcomes
Plasma calpain-1 activity
Inflammatory markers
Serum creatine kinase activity
Urinary titin fragment concentration
Muscle soreness
Range of motion
Transverse relaxation time
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
Duration: 6 days
Test food: 6-MSITC
Control food: Starch
Washout: 4 weeks
Administration: 3 mg 3 times a day, after meals (9 mg/day)
1. Test food
2. wash out period
3. Control food
Interventions/Control_2
Duration: same as above
Test food: same as above
Control food: same as above
Washout: same as above
Administration: same as above
1. Control food
2. Wash out period
3. Test food
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1. Participants who had no history of musculoskeletal injury or disease
2. Participants who had not engaged in regular resistance training
3. Participants who had not take any supplements and over-the-counter-medications
Key exclusion criteria
(1) Participants who had a history or signs of a heart or cerebrovascular disease
(2) Participants who had diabetes, a liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(3) Participants who had allergic reaction to food
(4) Participants who were judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Japan Institute of Sports Sciences
Division name
Department of Sports Research
Zip code
115-0056
Address
3-15-1, nishigaoka, kita-ku, tokyo
TEL
03-5963-0230
hideyuki.takahashi@jpnsport.go.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Japan Institute of Sports Sciences
Division name
Department of Sports Research
Zip code
115-0056
Address
3-15-1, nishigaoka, kita-ku, tokyo
TEL
03-5963-0230
Homepage URL
hideyuki.takahashi@jpnsport.go.jp
Sponsor or person
Institute
Japan Institute of Sports Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Institute of Sports Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Japan Institute of Sports Sciences
Address
3-15-1, nishigaoka, kita-ku, tokyo
Tel
03-5963-0230
hideyuki.takahashi@jpnsport.go.jp
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
国立スポーツ科学センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jpnsport.go.jp/jiss/Tabid/260/Default.aspx
Publication of results
Partially published
Result
URL related to results and publications
https://www.jpnsport.go.jp/jiss/Tabid/260/Default.aspx
Number of participants that the trial has enrolled
8
Results
Plasma calpain-1 concentration after eccentric exercise was similar between the placebo and 6-MSITC conditions. All muscle damage(creatine kinase activity, urinary titin concentration, muscle strength, range of motion, muscle soreness and transverse relaxation time) and inflammatory markers were not affected by 6-MSITC relative to those in the placebo condition.
Results date posted
| 2020 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young adults
Participant flow
8 participants completed and incorporated into the analyses
Adverse events
No adverse effect reported
Outcome measures
Maximal voluntary isometric contraction torque
Plasma calpain-1 activity
Inflammatory markers
Serum creatine kinase activity
Urinary titin fragment concentration
Muscle soreness
Range of motion
Transverse relaxation time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045937
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| Registered date | File name |
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