Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine (LEUCI)
Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
調査の概要
詳細な説明
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
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-
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Murcia、スペイン、30107
- Catholic University of Murcia
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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:
- Subjects of both sexes with age between 55-70 years.
- Body mass index less than 35.
- Subjects who have given written informed consent to participate in the study.
Exclusion Criteria:
- Consumption during the 6 months prior to the study of functional food enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
- Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
- Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, ischemic heart disease under treatment, arrhythmias, etc).
- Abuse in the ingestion of alcohol.
- Present hypersensitivity or intolerance to any of the components of the products under study.
- Inability to understand informed consent.
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：処理
- 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 |
|---|---|
|
実験的：Experimental group 1 (TS + placebo)
Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
実験的：Experimental group 2 (TS + leucine)
Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
実験的：Experimental group 3 (HRC + placebo)
Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
実験的：Experimental group 4 (HRC + leucine)
Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
実験的：Experimental group 5 (no physical exercise + leucine)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
介入なし：Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
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 |
|---|---|---|
|
Muscle mass
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
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Total fat mass
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
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Total fat free mass
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
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Fat free mass on upper limb
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Upper limb fat mass
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
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Fat-free mass in the lower limb
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
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Lower limb fat mass
時間枠：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Elbow extension
時間枠：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Upper limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Elbow flexion
時間枠：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Upper limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Knee extension
時間枠：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Lower limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Knee flexion
時間枠：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Lower limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Blood samples: Glycid metabolism and lipid metabolism.
時間枠：Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.
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Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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Liver safety variables
時間枠：Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver.
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Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
|
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 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- UCAMCFE-00013
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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