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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Self-Perception, Muscle Loss, Obesity, Obesity, Abdominal, Weight Loss, Happiness, Quality of Life, Stress, Psychological

Intervention / Treatment
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* Dietary Supplement: Multi-ingredient Pre-workout supplement
* Other: Progressive Resistance Training
* Behavioral: Nutritional Patterns Guideline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will intake a pre-workout multi-ingredient supplement. The second group will intake an isocaloric placebo containing only carbohydrates. The third group (control) will take a non-caloric placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Ingredient Pre-workout Supplement<br>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. | Dietary Supplement: Multi-ingredient Pre-workout supplement<br>* Every important issue has been detailed before.<br>* Other names: Preworkout;Other: Progressive Resistance Training<br>* The information about it has been detailed in advance.<br>* Other names: RT;Behavioral: Nutritional Patterns Guideline<br>* This intervention has also been described in advance.<br>* Other names: Healthy Eating;|
| Active Comparator: Isocaloric Placebo<br>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. | Other: Progressive Resistance Training<br>* The information about it has been detailed in advance.<br>* Other names: RT;Behavioral: Nutritional Patterns Guideline<br>* This intervention has also been described in advance.<br>* Other names: Healthy Eating;|
| Sham Comparator: Control<br>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. | Other: Progressive Resistance Training<br>* The information about it has been detailed in advance.<br>* Other names: RT;Behavioral: Nutritional Patterns Guideline<br>* This intervention has also been described in advance.<br>* Other names: Healthy Eating;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Mass | Assessment of the total adipose tissue via Bioelectrical Impedance. | Through study completion, an average of 1 year. | 
| Fat-free Mass | Assessment of the total lean mass via Bioelectrical Impedance. | Through study completion, an average of 1 year. | 
| Health Perception questionnaire | Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100). | 6 weeks. | 
| Pittsburgh Sleep Quality Index | Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). | 6 weeks. | 
| Stress Level and Mental Health | Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5). | 6 weeks. | 
| Adherence to a Mediterranean Diet (PREDIMED questionnaire) | Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5). | 6 weeks. | 
| International Physical Activity Questionnaire | 7 questions. Higher scores mean better outcomes (score from 1 to 5). | 6 weeks. | 
| Single-Leg balance | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the treatment (regular training, supplement intake and healthy eating) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Body Composition, Home-Based, Supplement, Multi-ingredient