이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)

2021년 12월 14일 업데이트: Joel Puente, University of Greenwich
The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.

연구 개요

상세 설명

The methodology will follow a Home-based, online, double-blinded, randomised, long-term design. The participants recruited will be active, middle-aged and older healthy adults. The supplement intake will be a Pre-workout supplement intake or a placebo intake. The exercise training will be a Progressive Resistance Training, with sessions of ~1 hour (3 times/week). The intervention will last for a minimum of one year and the possibility to prolong it to another one (two years of intervention) if the adherence to the treatment was higher to the 75% of the participants (of, at least, 85% of the training sessions and supplementation intake).

The outcomes that will be assessed are: Body composition (fat mass and fat-free mass), physical performance (short test designed by Go Fit Lab: single-leg standing balance, upper-body strength - maximum number of push-ups repetitions in 15 seconds -, lower-body mechanical power - vertical jump -, agility/velocity - 30 seconds of static running at maximum velocity -, recovery assessment - 60 seconds monitoring of heart rate after the previous test -), Happiness Score (designed by Go Fit, including different self-reported validated tests, such as: Par-Q+, ACSM Cardiovascular Risk Factors Questionnaire, SF-12 for quality of life and self-perceived health status, PSS-4 Stress and mental health, Pittsburgh Sleeping Quality test, PREDIMED test: adherence to Mediterranean diet eating patterns, and the IPAQ short form), and for every workout: Self-perceived energy feeling (Questionnaire: Energy Level, Fatigue, Alertness and Focus for the Task), Rate of Perceived Exertion (OMNI RES Scale and Borg Scale) and adherence to regular physical exercise practise, healthy nutritional patterns, and supplement intake.

연구 유형

중재적

등록 (예상)

3000

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Joel Puente Fernández, PhD Student
  • 전화번호: +34626610821
  • 이메일: jp2979a@gre.ac.uk

연구 연락처 백업

연구 장소

    • Avery Hill, London.
      • London, Avery Hill, London., 영국, SE9 2BT
        • University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT

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

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Healthy adults (no current injuries or illnesses which may interfere with the project).
  • Recreationally active adults (a minimum of 3 and a maximum of 5 days of training sessions per week: combining resistance and endurance).

Exclusion Criteria:

  • Participants younger than 40 or older than 70 years old.
  • Participants with hard injuries, disabilities or pathologies.
  • People taking medication or other supplements which may interfere with the multi-ingredient pre-workout or the training sessions.

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Multi-Ingredient Pre-workout Supplement

This group of participants will intake a multi-ingredient supplement around ~15 minutes before every workout.

The nutritional information of the supplement is: ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine: 2.5g, L-arginine AKG: 2.5g, L-Leucine: 800mg, Taurine: 500mg, L-citrulline: 500mg- 6.8 g, Creatine monohydrate: 2.0g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg.

They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).

Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.

The training sessions and the nutritional guideline will be the same for the three groups.

Every important issue has been detailed before.
다른 이름들:
  • Preworkout
The information about it has been detailed in advance.
다른 이름들:
  • RT
  • PRT
This intervention has also been described in advance.
다른 이름들:
  • 영양물 섭취
  • 건강한 식사
활성 비교기: Isocaloric Placebo

This group of participants will intake an isocaloric (only carbohydrates: Maltodextrin) supplement comparator, around ~15 minutes before every workout.

The nutritional information of the supplement is: ~90 Kcal. for 23g of powder.

They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).

Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.

The training sessions and the nutritional guideline will be the same for the three groups.

The information about it has been detailed in advance.
다른 이름들:
  • RT
  • PRT
This intervention has also been described in advance.
다른 이름들:
  • 영양물 섭취
  • 건강한 식사
가짜 비교기: Control

These participants will drink a non-caloric admixture with the same taste, texture and flavour.

They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).

Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.

The training sessions and the nutritional guideline will be the same for the three groups.

The information about it has been detailed in advance.
다른 이름들:
  • RT
  • PRT
This intervention has also been described in advance.
다른 이름들:
  • 영양물 섭취
  • 건강한 식사

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Fat Mass
기간: Through study completion, an average of 1 year.
Assessment of the total adipose tissue via Bioelectrical Impedance.
Through study completion, an average of 1 year.
Fat-free Mass
기간: Through study completion, an average of 1 year.
Assessment of the total lean mass via Bioelectrical Impedance.
Through study completion, an average of 1 year.
Health Perception questionnaire
기간: 6 weeks.

Short Form of 12 questions.

Higher scores mean better outcomes (score from 0 to 100).

6 weeks.
Pittsburgh Sleep Quality Index
기간: 6 weeks.

Short Form of 4 questions.

Higher scores mean better outcomes (score from 1 to 5).

6 weeks.
Stress Level and Mental Health
기간: 6 weeks.

Short Form of 4 questions.

Higher scores mean worse outcomes (score from 1 to 5).

6 weeks.
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
기간: 6 weeks.

Short Form of 4 questions.

Higher scores mean better outcomes (score from 1 to 5).

6 weeks.
International Physical Activity Questionnaire
기간: 6 weeks.

7 questions.

Higher scores mean better outcomes (score from 1 to 5).

6 weeks.
Single-Leg balance
기간: 6 Weeks

Standing in one leg only, be capable of holding the position for 15 seconds. Performed with the dominant leg at first and the non-dominant leg afterwards.

Score from 1 to 15 (higher scores mean better outcomes).

6 Weeks
Upper-Body push strength
기간: 6 Weeks

Number of push-ups in 15 seconds.

The score will be the number of Push-Ups performed (higher scores mean better outcomes).

6 Weeks
Lower-body mechanical power
기간: 6 Weeks

Jump height with countermovement.

The jump will be performed from a standing position, lateral to the wall and jumping to touch the wall as high as possible (with chalk in their finger-prints to mark the height they touched the wall).

The score will be the height of the jump (higher scores mean better outcomes).

6 Weeks
Recovery
기간: 6 Weeks

Static running in 1m2 square as fast as possible for 30 seconds and immediately after, Heart Rate will be monitored for 1 minute

The score will be the difference from the Maximum Heart Rate minus the Heart Rate after 1 minute recovery (higher scores mean better outcomes).

6 Weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Adherence to the treatment (regular training, supplement intake and healthy eating)
기간: 6 weeks
The compliance with the training and supplementation protocols will be measured constantly, as well as the healthy eating patterns. Those participants who have spent 7 days or more in a row without training or taking the supplement, as well as a final accomplishment of the 85% will be discarded from the final analysis.
6 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Fernando J Naclerio, Dr, University of Greenwich

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 (예상)

2023년 1월 1일

기본 완료 (예상)

2023년 5월 1일

연구 완료 (예상)

2023년 5월 28일

연구 등록 날짜

최초 제출

2020년 11월 8일

QC 기준을 충족하는 최초 제출

2020년 11월 13일

처음 게시됨 (실제)

2020년 11월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 12월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 14일

마지막으로 확인됨

2021년 12월 1일

추가 정보

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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