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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)

14. december 2021 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

3000

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Joel Puente Fernández, PhD Student
  • Telefonnummer: +34626610821
  • E-mail: jp2979a@gre.ac.uk

Undersøgelse Kontakt Backup

Studiesteder

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

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

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • Preworkout
The information about it has been detailed in advance.
Andre navne:
  • RT
  • PRT
This intervention has also been described in advance.
Andre navne:
  • Ernæring
  • Sund Ernæring
Aktiv komparator: 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.
Andre navne:
  • RT
  • PRT
This intervention has also been described in advance.
Andre navne:
  • Ernæring
  • Sund Ernæring
Sham-komparator: 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.
Andre navne:
  • RT
  • PRT
This intervention has also been described in advance.
Andre navne:
  • Ernæring
  • Sund Ernæring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fat Mass
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 weeks.

Short Form of 12 questions.

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

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

Short Form of 4 questions.

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

6 weeks.
Stress Level and Mental Health
Tidsramme: 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)
Tidsramme: 6 weeks.

Short Form of 4 questions.

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

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

7 questions.

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

6 weeks.
Single-Leg balance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence to the treatment (regular training, supplement intake and healthy eating)
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studieleder: Fernando J Naclerio, Dr, University of Greenwich

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 (Forventet)

1. januar 2023

Primær færdiggørelse (Forventet)

1. maj 2023

Studieafslutning (Forventet)

28. maj 2023

Datoer for studieregistrering

Først indsendt

8. november 2020

Først indsendt, der opfyldte QC-kriterier

13. november 2020

Først opslået (Faktiske)

16. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2021

Sidst verificeret

1. december 2021

Mere information

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