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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Murcia, Spania, 30107
- Catholic University of Murcia
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Ingen inngripen: Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle mass
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Total fat mass
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Total fat free mass
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Fat free mass on upper limb
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Upper limb fat mass
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Fat-free mass in the lower limb
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Lower limb fat mass
Tidsramme: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Elbow extension
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
|
Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.
|
Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
|
|
Liver safety variables
Tidsramme: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
|
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.
|
Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UCAMCFE-00013
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