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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000040273
Receipt No. 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

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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
Email 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
Email hideyuki.takahashi@jpnsport.go.jp

Sponsor
Institute Japan Institute of Sports Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045937

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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