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

20 maj 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

142

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: 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
Experimentell: 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.
Kosttillskott: 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
Experimentell: 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.
Kosttillskott: 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
Experimentell: 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.
Kosttillskott: 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
Experimentell: 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.
Kosttillskott: 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
Inget ingripande: Control (no physical exercise + placebo)

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

Daily consumption for 3 months of placebo milk.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Muscle mass
Tidsram: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat mass
Tidsram: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat free mass
Tidsram: 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
Tidsram: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Upper limb fat mass
Tidsram: 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
Tidsram: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Lower limb fat mass
Tidsram: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Elbow extension
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidad Católica San Antonio de Murcia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 november 2019

Primärt slutförande (Faktisk)

15 februari 2020

Avslutad studie (Faktisk)

30 april 2020

Studieregistreringsdatum

Först inskickad

8 april 2020

Först inskickad som uppfyllde QC-kriterierna

11 april 2020

Första postat (Faktisk)

14 april 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 maj 2020

Senast verifierad

1 april 2020

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • UCAMCFE-00013

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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