UMIN-CTR Clinical Trial
| 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 (Ver. 1) |
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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 | |
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| Condition | ||
| Condition | Healthy adults | |
| Classification by specialty |
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| 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 |
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| 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 |
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| 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 |
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| Interventions/Control_3 | ||
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| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 8 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Healthy young adults |
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| Participant flow | 8 participants completed and incorporated into the analyses |
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| Adverse events | No adverse effect reported |
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| 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 |
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| Progress | |||||||
| Recruitment status | Main results already published | ||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045937 |
