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Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine (LEUCI)

20 maggio 2020 aggiornato da: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months

Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

142

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Murcia, Spagna, 30107
        • Catholic University of Murcia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 55 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Integratore alimentare: dietary supplement consumption

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
Sperimentale: 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.
Integratore alimentare: dietary supplement consumption

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
Sperimentale: 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.
Integratore alimentare: dietary supplement consumption

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
Sperimentale: 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.
Integratore alimentare: dietary supplement consumption

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
Sperimentale: 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.
Integratore alimentare: dietary supplement consumption

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
Nessun intervento: Control (no physical exercise + placebo)

The subjects will not carry out any type of physical activity.

Daily consumption for 3 months of placebo milk.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscle mass
Lasso di tempo: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat mass
Lasso di tempo: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat free mass
Lasso di tempo: 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
Lasso di tempo: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Upper limb fat mass
Lasso di tempo: 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
Lasso di tempo: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Lower limb fat mass
Lasso di tempo: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Elbow extension
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Católica San Antonio de Murcia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 novembre 2019

Completamento primario (Effettivo)

15 febbraio 2020

Completamento dello studio (Effettivo)

30 aprile 2020

Date di iscrizione allo studio

Primo inviato

8 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

11 aprile 2020

Primo Inserito (Effettivo)

14 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • UCAMCFE-00013

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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