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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Murcia, Испания, 30107
- Catholic University of Murcia
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
|
Без вмешательства: Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Muscle mass
Временное ограничение: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Total fat mass
Временное ограничение: Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Total fat free mass
Временное ограничение: Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
|
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Fat free mass on upper limb
Временное ограничение: Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
|
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Upper limb fat mass
Временное ограничение: Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Fat-free mass in the lower limb
Временное ограничение: Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Lower limb fat mass
Временное ограничение: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Elbow extension
Временное ограничение: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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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).
|
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Elbow flexion
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).
|
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Blood samples: Glycid metabolism and lipid metabolism.
Временное ограничение: 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
Временное ограничение: 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.
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- UCAMCFE-00013
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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