UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000033141 |
| Receipt No. | R000037799 |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/06/28 |
| Last modified on | 2020/01/11 (Ver. 8) |
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| Basic information | ||
| Public title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial | |
| Acronym | Influence of eicosapentaenoic acid on muscular endurance and vascular endothelial function | |
| Scientific Title | Influence of ingestion of eicosapentaenoic acid-rich fish oil on muscular endurance and vascular endothelial function : a randomized, double-blind, placebo-controlled, parallel-group trial | |
| Scientific Title:Acronym | Influence of eicosapentaenoic acid on muscular endurance and vascular endothelial function | |
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| Condition | |||
| Condition | vascular endothelial function | ||
| Classification by specialty |
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| Classification by malignancy | Others | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | The purpose of this study is to investigate the influence of eicosapentaenoic acid for vascular endothelial function and muscular endurance performance after exercise |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | After ingestion of tested materials for 8 weeks, we will measure the flow-mediated dilatation before and after exercise |
| Key secondary outcomes | 1) maximal isometric torque
2) RPE 3) oxygen saturation in skeletal muscle |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| 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 | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | Tested material: EPA-rich fish oil
Dosage: 2.4g/day Duration: 8 weeks |
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| Interventions/Control_2 | Tested material: corn oil
Dosage: 2.4g/day Duration: 8 weeks |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male | |||
| Key inclusion criteria | Healthy male subjects | |||
| Key exclusion criteria | Subjects with
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study |
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| Target sample size | 24 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Hosei University | ||||||
| Division name | Faculty of Bioscience and Applied Chemistry | ||||||
| Zip code | 184-8584 | ||||||
| Address | 3-7-2 Kajino, Koganei, Tokyo | ||||||
| TEL | 042-387-6337 | ||||||
| ochi@hosei.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Hosei University | ||||||
| Division name | Faculty of Bioscience and Applied Chemistry | ||||||
| Zip code | 184-8584 | ||||||
| Address | 3-7-2 Kajino, Koganei, Tokyo | ||||||
| TEL | 042-387-6337 | ||||||
| Homepage URL | |||||||
| ochi@hosei.ac.jp | |||||||
| Sponsor | |
| Institute | Hosei University
Faculty of Bioscience and Applied Chemistry |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Nippon Suisan Kaisha Ltd. |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Research Ethics Committee of Hosei University, Faculty of Bioscience and Applied Chemistry |
| Address | 3-7-2 Kajino, Koganei, Tokyo |
| Tel | 042-783-2732 |
| tamatai@hosei.ac.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 | 法政大学生命科学部（東京都）
（Hosei Univesity Faculty of Bioscience） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000037799 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/31671276 | ||||||
| Number of participants that the trial has enrolled | 19 | ||||||
| Results | Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups. Similarly, there is no significant difference in the oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability, between the groups. Also, MVC and blood lactate did not change between groups. |
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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 |
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| Baseline Characteristics | healthy men |
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| Participant flow | Nineteen healthy men were randomly assigned to a placebo group or EPA+DHA group in a double-blind fashion. The EPA+DHA group was administered EPA-rich fish oil, containing 600 mg EPA and 260 mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time. |
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| Adverse events | Nothing |
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| Outcome measures | Repetitions, MVC, FMD, StO2 |
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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=R000037799 |
