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

2020년 5월 20일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

142

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Murcia, 스페인, 30107
        • Catholic University of Murcia

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

실험적: 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

실험적: 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

실험적: 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

실험적: 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

간섭 없음: Control (no physical exercise + placebo)

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

Daily consumption for 3 months of placebo milk.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Muscle mass
기간: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat mass
기간: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Total fat free mass
기간: 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
기간: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Upper limb fat mass
기간: 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
기간: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.
Lower limb fat mass
기간: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Change of this measurement at 3 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Elbow extension
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 11월 15일

기본 완료 (실제)

2020년 2월 15일

연구 완료 (실제)

2020년 4월 30일

연구 등록 날짜

최초 제출

2020년 4월 8일

QC 기준을 충족하는 최초 제출

2020년 4월 11일

처음 게시됨 (실제)

2020년 4월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 5월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 20일

마지막으로 확인됨

2020년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • UCAMCFE-00013

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