Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes (O3Sport)
2015年11月19日 更新者：FRANCISCO DROBNIC, MD, PhD、Centre d'Alt Rendiment
Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response
A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered necessary for a good cell function and prevention of various inflammatory processes.
Diet and supplementation are the fundamental procedures to achieve the reference values for several years.
Athletes are individuals under physical stress and higher tissue restoration, while maintaining adequate diets they show, as the rest of humans, lower than desired levels.
In the present study the investigators aims to determine the modification of those levels by the administration of two different doses of a given product, keeping the same model of diet and physical and competition.
調査の概要
詳細な説明
The study aims to assess concentrations of the different fatty acids in the erythrocyte membrane before and after administration of a compound with high quality omega3 (EPA and DHA) in two different doses, compared with control group .
The period of evaluation and management is four months, one month for the proposed renewal of red blood cells.
The composition of the diet, the sports calendar, caloric expenditure and level of training is determined.
During the study process it is excluded subjects with injuries or disease processes and ensure that no one take any supplement or modify workouts or diet.
研究の種類
介入
入学 (実際)
24
段階
- 初期フェーズ 1
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy, young men and women athletes from the Olympic Training Center (OTC) of Sant Cugat del Valles in Barcelona (Spain) (20 to 45 years of age) belonging to different summer sport activities were asked to participate.
Exclusion Criteria:
- Any type of inflammatory process, or the use of anti-inflammatory medications, consumption of n-3 Fatty Acids (FA) supplements and n-3 FA-supplemented foods in the past 3 months; planning to change dietary habits, or training schedule.
- During the study, any subject that falls under injury or need nonsteroidal antiinflammatory drug or get sick by inflammatory or infectious disease.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：2 Gums
Athletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
|
760 mg DHA
|
|
実験的：3 Gums
Athletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.
|
1140 mg DHA
|
|
介入なし：Control
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
fatty acid levels at the membrane of the red blood cells
時間枠：Four months
|
Evaluation will be obtained before and after the experimental period
|
Four months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impregnation in relation to dosage administrated to the athletes
時間枠：Four months
|
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristics, sex (M,F), omega3 index (EPA/DHA%), weight (kg), age(years), etc. looking for a relationships of better or worse impregnation depending on sex, body weight, body mass index, previous level of omega3, etc.
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and weight of the athletes
時間枠：Four months
|
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristics, weight (kg).
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different previous omega 3 index of the athletes
時間枠：Four months
|
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristic of previous level of omega3 index (EPA/DHA%)
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different sex of the athletes
時間枠：Four months
|
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the sex (M,F) of the subjects
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different age of the athletes
時間枠：Four months
|
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the age(years) of the subjects etc.
|
Four months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Franchek Drobnic, MD PhD、Olympic Training Center, Centre d'Alt Rendiment CAR
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年6月1日
一次修了 (実際)
2015年1月1日
研究の完了 (実際)
2015年4月1日
試験登録日
最初に提出
2015年11月13日
QC基準を満たした最初の提出物
2015年11月19日
最初の投稿 (見積もり)
2015年11月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月20日
QC基準を満たした最後の更新が送信されました
2015年11月19日
最終確認日
2015年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。