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)
NCT ID: NCT04630977
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3000 participants
INTERVENTIONAL
2023-01-01
2023-05-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The third group (control) will take a non-caloric placebo.
TREATMENT
TRIPLE
Study Groups
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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.
Multi-ingredient Pre-workout supplement
Every important issue has been detailed before.
Progressive Resistance Training
The information about it has been detailed in advance.
Nutritional Patterns Guideline
This intervention has also been described in advance.
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.
Progressive Resistance Training
The information about it has been detailed in advance.
Nutritional Patterns Guideline
This intervention has also been described in advance.
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.
Progressive Resistance Training
The information about it has been detailed in advance.
Nutritional Patterns Guideline
This intervention has also been described in advance.
Interventions
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Multi-ingredient Pre-workout supplement
Every important issue has been detailed before.
Progressive Resistance Training
The information about it has been detailed in advance.
Nutritional Patterns Guideline
This intervention has also been described in advance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
70 Years
ALL
Yes
Sponsors
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Ingesport Health Spa Consulting
UNKNOWN
University of Greenwich
OTHER
Responsible Party
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Joel Puente
Principal Investigator
Principal Investigators
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Fernando J Naclerio, Dr
Role: STUDY_DIRECTOR
University of Greenwich
Locations
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University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
London, Avery Hill, London., United Kingdom
Countries
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Central Contacts
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Other Identifiers
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UGreenwich2
Identifier Type: -
Identifier Source: org_study_id