オメガ3とホエイプロテインの補給が高齢者の除脂肪体重に及ぼす影響 (W-3 and Whey)
抵抗運動を行う高齢者の除脂肪体重と筋力増加に対するオメガ-3とホエイプロテインの補給の効果：無作為化二重盲検プラセボ対照研究
To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass, muscle strength, metabolomic and lipidomic profiles, and biomarkers of oxidative stress and inflammation in older adults undergoing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. All will perform the same exercise protocol for 12 weeks.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Minas Gerais
-
Uberlândia、Minas Gerais、ブラジル、38400-902
- Federal University of Uberlandia
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Postmenopausal women (at least 1 year of menstrual interruption, self-reported);
- To be able to practice strength exercises;
- To be able to carry out supplementation;
- Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;
- No history of stroke or acute myocardial infarction;
- Not being a smoker and/or alcoholic;
- Do not perform hormone replacement therapy;
- Do not use anti-inflammatory drugs;
- To have normal kidney function;
- To submit a medical certificate of health that proves that the individual is able to perform exercises.
Exclusion Criteria:
- Do not provide the necessary information for the development of the study;
- Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, cardiovascular, and kidney and/or liver diseases.
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo Group
Group supplemented with maltodextrin (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks |
The placebo group will receive 5 g per day of sunflower oil and 38 g per day of maltodextrin. |
|
実験的：Whey Protein + Placebo
Group supplemented with isolated whey protein (38g/day) and sunflower oil (5g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The whey protein + placebo group will receive 38g per day of whey and 5g per day of sunflower oil. |
|
実験的：Omega 3 + Placebo
Group supplemented with omega-3 (5g/day) and maltodextrin (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The omega 3 + placebo group will receive 5 g per day of fish oil and 38 g per day of maltodextrin. |
|
実験的：Omega 3 + Whey Protein
Group supplemented with omega-3 (5g/day) and whey protein (38g/day). All groups will undergo a training program with strength exercises for 12 weeks. |
The omega 3 + whey group will receive 5g per day of fish oil and 38g per day of protein. |
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 |
時間枠 |
|---|---|
|
Changes in lean mass (kg) using ultrasound and dual-energy X-ray absorptiometry (DXA) in postmenopausal women
時間枠：up to 12 weeks
|
up to 12 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
閉経後の女性におけるダイナモメーターを使用した筋力（kg）の変化
時間枠：最大12週間
|
最大12週間
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of oxidative stress and inflammation biomarkers
時間枠：up to 12 weeks
|
Oxidative stress biomarkers will be assessed in blood and saliva, whereas inflammatory biomarkers will be assessed in blood only. Blood and saliva samples will be collected before and after the intervention. After an overnight fast, 20 mL of blood will be collected into heparinized tubes. A portion of the blood will be used for whole-blood stimulation with or without 10 ng/mL lipopolysaccharide (LPS; Escherichia coli O111) for 6 hours at 37°C in 5% CO₂. Following incubation, the supernatant will be collected for the assessment of inflammatory cytokines by ELISA. The remaining blood will be centrifuged at 4°C and 3,200 rpm for 10 minutes, aliquoted, and stored at -80°C until analysis of oxidative stress biomarkers. |
up to 12 weeks
|
|
Metabolomics and lipidomics analyses
時間枠：up to 12 weeks
|
For metabolomic analysis, 100 μL of serum will be extracted with spectroscopic-grade methanol, homogenized, centrifuged, concentrated under vacuum, reconstituted in methanol, and filtered through a 0.22-μm filter. For lipidomic analysis, 100 μL of serum will be extracted using dichloromethane and methanol. The organic phase will be collected, concentrated under vacuum at 40°C, reconstituted in dichloromethane, and transferred to analytical vials. Metabolomic and lipidomic profiles will be analyzed using liquid chromatography coupled with high-resolution mass spectrometry (LC-MS) and gas chromatography coupled with mass spectrometry (GC-MS). Metabolites and lipids will be identified based on accurate mass, mass spectral data, and comparison with databases and published literature. |
up to 12 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 5.728.049
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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