重度のエネルギー不足と回復時のテストステロンの生理的および心理的影響 (OPS)
2019年1月3日 更新者:Jennifer C. Rood、Pennington Biomedical Research Center
重度のエネルギー不足と回復中のテストステロンの生理学的および心理的影響:無作為化プラセボ対照試験
この研究の目的は、重度の持続的なエネルギー不足の間、正性腺状態を維持することが、生理的減少、特に除脂肪体重の減少を軽減するかどうかを判断することです。
調査の概要
詳細な説明
この研究では、3 段階の無作為化プラセボ対照試験に最大 60 人の身体的に活動的な男性を登録します。
14 日間 (自由生活、フェーズ 1)、十分なエネルギー、食事順応フェーズ (タンパク質、1.6 g∙kg-1∙d-1、脂肪 30% の総エネルギー摂取量、残りのエネルギーは炭水化物由来) を完了した後)、参加者は 2 つの実験グループのいずれかに無作為に割り付けられ、28 日間 (住み込み、フェーズ 2)、55% のエネルギー不足フェーズ: エネルギー不足のみ (DEF) またはエネルギー不足 + 外因性テストステロン (DEF+TEST) .
回復(自由生活、フェーズ3)は、フェーズ2の完了後に評価され、体重が初期体重の±2.5%以内に回復した時期を判断します(期間は異なります。フェーズ3の最大42日)。
この研究は、物理的および心理的状態の複雑なマーカーに関する軍事訓練および戦闘作戦中に戦闘機が遭遇する身体的および精神的要求からのテストステロン低下の寄与を描写し、直接的で一貫して観察された知識のギャップに対処します.
研究の種類
介入
入学 (実際)
53
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
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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
18年~39年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
包含基準:
- 身体的にアクティブ(少なくとも週に 2 日有酸素運動および/またはレジスタンス運動)
- -処方薬を服用していない、および/または治験担当医によって提供/承認されていない限り、全治験期間中および/またはすべての投薬を控える意思がある
-アルコール、喫煙、電子タバコ、またはニコチン製品の使用、カフェイン、および栄養補助食品の使用を研究期間全体を通して控えることをいとわない
- -治験担当医の裁量により、医薬品、サプリメント、市販薬のウォッシュアウト期間は1〜4週間以上です
- カフェインとアルコールのウォッシュアウト期間は 7 日以上
- -ペニントン生物医学研究センターの入院ユニットに28日間連続して住むことをいとわない
- -尿中薬物スクリーニングを希望する
- 陸軍規則 600-9 に従って、年齢別の米国陸軍の体組成基準を満たしています。これには、身長、体重、周囲 (首と腰) に基づく体脂肪率の推定値が含まれます。
- 総テストステロン濃度は、正常な生理学的範囲、総テストステロン (300-1,000 ng/dL) 内にあります。
除外基準:
- 運動能力を損なう筋骨格損傷
- 診断された心臓代謝障害(すなわち、高血圧、高脂血症、腎臓病、糖尿病など)
- 食物に対するアレルギーまたは不耐性、菜食主義者の習慣、またはリドカインによる合併症の病歴
- アナボリックステロイド、ヒト成長ホルモン、または栄養テストステロン前駆体様サプリメントの過去6か月以内の使用
- -研究中に喫煙(ニコチン製品)、アルコール、カフェイン、またはその他の栄養補助食品を控えません
- -局所抗生物質を除く抗生物質の使用 研究参加から3か月以内
- -研究参加から3か月以内の大腸内視鏡検査
- 下剤、便軟化剤、制酸剤、または止瀉薬の慢性使用(週1回以上)
- -胃腸疾患の病歴(セリアック病、過敏性腸症候群、大腸炎、クローン病など)
- 研究の心理的および行動的評価スタッフによって評価された、拘束された食事(三要素摂食アンケート)
- 同意できない大人
- 女性
- 囚人
- 金属製のインプラント、閉所恐怖症、頭部サイズが MRI 装置に適合しないなど。
- 座りっぱなし、または週に 2 日未満の身体活動 (有酸素運動および/またはレジスタンス トレーニング) を行っている
- 陸軍規則 600-9 に従って、年齢別の米国陸軍体組成基準を上回っています。
- -医学研究者による別段の承認がない限り、腎臓結石の既往歴
- 収縮期血圧 > 150 または拡張期血圧 > 95 mmHg
- 乳がんまたは前立腺がんの既往歴
- 慢性閉塞性肺疾患または閉塞性睡眠時無呼吸の既往歴
- -前立腺特異抗原> 3ng / ml、ヘマトクリット> 50%、または陽性の尿薬物スクリーニングの検査結果の所見
- -調査チームの臨床的判断に基づいて、被験者は研究への参加に適していない可能性があります
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:エネルギー不足
コントロール条件にランダムに割り当てられた参加者は、運動によるエネルギー消費の影響を受け、55% のエネルギー不足が生じ、試験のフェーズ 2 でゴマ油プラセボ注射が投与されます。
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15、21、28、および 35 日目に週 1 回、筋肉内注射による 200 mg のゴマ油
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実験的:エネルギー不足 + テストステロン
介入条件にランダムに割り当てられた参加者は、運動によるエネルギー消費の影響を受け、55% のエネルギー不足が生じ、試験の第 2 段階でエナント酸テストステロン注射が投与されます。
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15、21、28、および 35 日目に週 1 回、筋肉内注射による 200 mg のテストステロン エナンテート
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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 |
|---|---|---|
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各試験段階終了時の体組成
時間枠:各研究フェーズの終わり: フェーズ 1 では 11 日目、フェーズ 2 では 39 日目、フェーズ 3 では 85 日目まで
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身長はスタディオメーターで測りました。
重量は、校正済みのデジタル スケールを使用して測定されました。
体組成は、二重エネルギー X 線吸収法を使用して決定されました。
これらのデータを使用して、除脂肪体重、体脂肪量、および全身組織量を計算しました。
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各研究フェーズの終わり: フェーズ 1 では 11 日目、フェーズ 2 では 39 日目、フェーズ 3 では 85 日目まで
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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。
協力者
捜査官
- 主任研究者:Jennifer C Rood, Ph.D.、Pennington Biomedical Research Center
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。
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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 (実際)
2016年4月1日
一次修了 (実際)
2017年12月1日
研究の完了 (実際)
2017年12月1日
試験登録日
最初に提出
2016年3月31日
QC基準を満たした最初の提出物
2016年4月5日
最初の投稿 (見積もり)
2016年4月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月16日
QC基準を満たした最後の更新が送信されました
2019年1月3日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PBRC 2015-063
個々の参加者データ (IPD) の計画
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いいえ
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