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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 dicembre 2021 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

3000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Joel Puente Fernández, PhD Student
  • Numero di telefono: +34626610821
  • Email: jp2979a@gre.ac.uk

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Preworkout
The information about it has been detailed in advance.
Altri nomi:
  • RT
  • PRT
This intervention has also been described in advance.
Altri nomi:
  • Nutrizione
  • Alimentazione Sana
Comparatore attivo: 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.
Altri nomi:
  • RT
  • PRT
This intervention has also been described in advance.
Altri nomi:
  • Nutrizione
  • Alimentazione Sana
Comparatore fittizio: 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.
Altri nomi:
  • RT
  • PRT
This intervention has also been described in advance.
Altri nomi:
  • Nutrizione
  • Alimentazione Sana

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fat Mass
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 weeks.

Short Form of 12 questions.

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

6 weeks.
Pittsburgh Sleep Quality Index
Lasso di tempo: 6 weeks.

Short Form of 4 questions.

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

6 weeks.
Stress Level and Mental Health
Lasso di tempo: 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)
Lasso di tempo: 6 weeks.

Short Form of 4 questions.

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

6 weeks.
International Physical Activity Questionnaire
Lasso di tempo: 6 weeks.

7 questions.

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

6 weeks.
Single-Leg balance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence to the treatment (regular training, supplement intake and healthy eating)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Fernando J Naclerio, Dr, University of Greenwich

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 gennaio 2023

Completamento primario (Anticipato)

1 maggio 2023

Completamento dello studio (Anticipato)

28 maggio 2023

Date di iscrizione allo studio

Primo inviato

8 novembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

13 novembre 2020

Primo Inserito (Effettivo)

16 novembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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