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

20. maj 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

142

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Murcia, Spanien, 30107
        • Catholic University of Murcia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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
Eksperimentel: 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.
Kosttilskud: 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
Eksperimentel: 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.
Kosttilskud: 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
Eksperimentel: 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.
Kosttilskud: 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
Eksperimentel: 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.
Kosttilskud: 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
Ingen indgriben: Control (no physical exercise + placebo)

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

Daily consumption for 3 months of placebo milk.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Católica San Antonio de Murcia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. november 2019

Primær færdiggørelse (Faktiske)

15. februar 2020

Studieafslutning (Faktiske)

30. april 2020

Datoer for studieregistrering

Først indsendt

8. april 2020

Først indsendt, der opfyldte QC-kriterier

11. april 2020

Først opslået (Faktiske)

14. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UCAMCFE-00013

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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