- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04345237
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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Murcia, Espanja, 30107
- Catholic University of Murcia
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Ei väliintuloa: Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Muscle mass
Aikaikkuna: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Total fat mass
Aikaikkuna: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Total fat free mass
Aikaikkuna: 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
Aikaikkuna: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Upper limb fat mass
Aikaikkuna: 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
Aikaikkuna: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
|
Lower limb fat mass
Aikaikkuna: Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Elbow extension
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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