| 目的/Objectives |
| 目的1/Narrative objectives1 |
エイコサペンタエン酸（EPA）等の多価不飽和脂肪酸を高含有する魚油は、その抗炎症作用等から遅発性筋痛の抑制が期待されている。しかし、EPA摂取による筋痛への効果はまだ明確になっていない。本研究では、EPA高含有魚油を投与した被験者に伸張性収縮等の運動を負荷した際の影響を評価し、EPAの遅発性筋痛への効果を明らかにすることを目的とする。 |
Fish oils mainly compose of polyunsaturated fatty acids including eicosapentaenoic acid (EPA). Because EPA is especially reported for high anti-inflammatory activity, EPA-rich fish oil may possess the effect on delayed onset muscle soreness (DOMS).
The purpose of this study is investigating the influence of EPA for DOMS following eccentric contractions.
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| 目的2/Basic objectives2 |
有効性/Efficacy |
| 目的2 -その他詳細/Basic objectives -Others |
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| 試験の性質1/Trial characteristics_1 |
検証的/Confirmatory |
| 試験の性質2/Trial characteristics_2 |
実務的/Pragmatic |
| 試験のフェーズ/Developmental phase |
該当せず/Not applicable |
| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
１．被験食を8週間摂取後、伸張性収縮を非利き手の上腕筋群に負荷する。伸張性収縮前、伸張性収縮直後、1日後、2日後、3日後、5日後における
１）最大等尺性トルク
２）関節可動域
３）上腕周径囲
４）痛みに関するVisual Analog Scale
５）血液検査（クレアチニンキナーゼ、ミオグロビン、IL-6、TNF-α）
２．伸張性収縮負荷時の上腕筋の仕事量
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I. After ingestion of tested materials for 8 weeks, subjects perform eccentric contraction with elbow flexors.
Before ECC, at 0, 1,2,3,5days after ECC
1. maximal isometric torque
2. range of motion
3. upper arm circumference
4. muscle soreness measured as a visual analog scale
5. blood test creatine kinase, myoglobin,IL-6, TNF-alpha
II. work output of elbow flexors during ECC
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| 副次アウトカム評価項目/Key secondary outcomes |
被験食摂取期間前後における体重、身長、体脂肪率 |
Before and after ingestion of tested materials, weight, height and body fat percentage |
| 介入/Intervention |
| 群数/No. of arms |
2 |
| 介入の目的/Purpose of intervention |
予防・検診・検査/Prevention |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
被験食：EPA高含有魚油
摂取量：2.4g/日
摂取期間：8週間 |
Tested material: EPA-rich fish oil
Dosage: 2.4g/day
Duration: 8 weeks
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| 介入2/Interventions/Control_2 |
被験食：コーン油
摂取量：2.4g/日
摂取期間：8週間 |
Tested material: corn oil
Dosage: 2.4g/day
Duration: 8 weeks
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男/Male |
| 選択基準/Key inclusion criteria |
健康であること |
Healthy male subjects |
| 除外基準/Key exclusion criteria |
・定期的な筋肉負荷トレーニングをしている者
・日常全く運動をしていない者
・試験への参加に同意が得られなかった者
・重篤な肝臓、腎臓、心臓、呼吸器、内分泌、代謝疾患を有している者
・試験期間中、手術の予定のある者
・試験期間中、摂取中止の出来ない医薬品を常用されている者
・研究結果への影響が考えられる食品を日常的に摂取している者
・魚アレルギーのある者
・他の臨床試験に参加している者
・運動に制限のある者
・臨床研究責任者が本試験参加に適切でないと判断した者 |
Subjects with
/regular resistance training /no exercise /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular consumption of other functional foods for muscle soreness/ food allergies to fish/ 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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| 目標参加者数/Target sample size |
24 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4875060/ |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
24 |
| 主な結果/Results |
MVCおよびROMにおいて有意な摂取効果が認められた。 |
MVC was significantly higher in the EPA group than in the PL group at 2 - 5 days after exercise (p < 0.05). ROM
was also significantly greater in the EPA group than in the
PL group at 1 - 5 days after exercise (p < 0.05). At only
3 days after exercise, muscle soreness of the brachialis
was significantly greater in the PL group than in the EPA
group (p < 0.05), with a concomitant increase in serum
IL-6 levels in the PL group. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
健常男性 |
Healthy men |
| 参加者の流れ/Participant flow |
ランダムに2群に分け、EPAあるいはコーン油を８週摂取した。その後、運動を実施し、関連項目を測定した |
Twenty-four healthy men were randomly assigned to consume the EPA + DHA supplement (EPA, n = 12) or placebo (PL, n = 12) by the double-blind method. Participants consumed EPA + DHA or placebo supplement for 8 weeks prior to exercise and continued it until 5 days after exercise. |
| 有害事象/Adverse events |
なし |
Nothing
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| 評価項目/Outcome measures |
MVC torque, range of motion (ROM), upper arm circumference, muscle soreness as well as serum creatine kinase, myoglobin, IL-6, and TNF-α levels in blood |
MVC torque, ROM, upper arm circumference, muscle soreness as well as serum creatine kinase, myoglobin, IL6, and TNF levels in blood |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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UMIN-CTR 臨床試験登録情報の閲覧