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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Murcia, Hiszpania, 30107
- Catholic University of Murcia
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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 |
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Eksperymentalny: 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 |
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Eksperymentalny: 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 |
|
Eksperymentalny: 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 |
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Eksperymentalny: 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 |
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Brak interwencji: Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Muscle mass
Ramy czasowe: 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 mass
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Elbow extension
Ramy czasowe: 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.
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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
Ramy czasowe: 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.
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This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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Knee extension
Ramy czasowe: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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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.
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This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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Knee flexion
Ramy czasowe: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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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.
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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.
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- UCAMCFE-00013
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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