Effects of a Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing in Adults.

Study Overview
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Brief Summary
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The investigation will be conducted as a double blinded, randomized, parallel between treatment conditions comparison design with two different groups ingesting a different supplement each one.

Detailed Description
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Following inclusion, familiarization and baseline assessments, the participants will be randomly allocated to receive either a multi-ingredient, pre-workout supplement (PREW) or maltodextrin (CHO). Thereafter, the participants will follow a 6-weeks resistance training mesocycle, involving three resistance training sessions (Monday, Wednesday and Friday) per week (18 sessions in total). Before and after the 6 weeks of intervention, the following assessments will be performed: (i) Body composition (fat mass and fat-free mass) via air displacement plethysmography (BodPod); (ii) muscle contractile properties on Vastus Medialis and Anterior Deltoids (via Tensiomyography; (iii) muscle structure of the Vastus Lateralis of the Quadriceps and the Elbow Flexors of dominant extremities via Ultrasound; (iv) Maximal Isometric Strength (Isometric Mid-Thigh Pull); (v) Upper and Lower Body Muscular Power (Medicine Ball Throw and Vertical Jump), (vi) Upper and Lower Muscular Endurance (30-Seconds Sit-to-Stand and 30-Seconds 16RM Bench Press), (vii) Immune System (via HemoCue WBC DIFF System). The supplements will be ingested 15 min before each training session. Energy Feeling Questionnaire will be filled immediately before warming up. In addition, Rate of Perceived Exertion to training will be assessed 15 min after the completion of all workouts.

Official Title
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Effects of a Protein-Based Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Perceptual Responses, Energy Feelings and Muscular Properties, in Middle-Aged and Older Adults.

Conditions
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Protein Deficiency, Training Group, Sensitivity, Fatigue, Muscular Atrophy, Psychological

Intervention / Treatment
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* Dietary Supplement: Ingestion of a Pre-Workout Supplement
* Dietary Supplement: Ingestion of a Maltodextrin Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (no injuries, illnesses or medication intake). Between 45 and 65 years old. Active and familiarised with Resistance Training. Exclusion Criteria: Unhealthy (illnesses or medication intake) or injured. Untrained. Young (<45 y.o.) or elderly (>65 y.o.).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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: 6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Ingredient Pre-Workout Supplement<br>A 60 g dose of a commercially available preworkout supplement providing 159 kcal including carbohydrates 15 g, essential amino acids 12 g, citrulline 3.5 g, Arginine, 3.5 g Taurine 1 g, L-Tyrosine 1 g, yerba mate 0.3 g and caffeine 0.4 g. With 350 ml of water. | Dietary Supplement: Ingestion of a Pre-Workout Supplement<br>* The Multi-Ingredient Pre-Workout Supplement is administered 15 minutes before the beginning of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.<br>|
| Placebo Comparator: Maltodextrin Supplement<br>A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water. | Dietary Supplement: Ingestion of a Maltodextrin Supplement<br>* The Maltodextrin Supplement is administered 15 minutes before the beginning of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tensiomyography | A TMG portable device (TMG Measurement System, 146 TMG-BMC Ltd., Ljubljana, Slovenia) with a maximal stimulation output of 110 mA·ms-1 IS used to evaluate the contractile properties of the Anterior Deltoid (AD) of the dominant limb. Changes in the evoked muscular contractile properties are estimated by analysing maximal radial displacement of the muscle belly in millimetres (Dm). | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Vertical Jump | Height (measured in centimetres) | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Chest Medicine Ball Throw | Medicine Ball Throw (measured in meters and centimetres). | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Maximal Mid-Thigh Pull Isometric Strength | Maximal Strength (measured in kilograms). | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Muscle Thickness | Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Self Perceived Energy Feeling | All participants will fill a short questionnaire (from 1 to 5 points) about their perception of energy before every training. Energy Feeling will be assessed (Evergy level, Fatigue Level, Feeling of Alertness, and Feeling of Focus for the task, valued from 1 = low energy to 5 = high energy). | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 
| Whole Body Perceptual Response during Resistance Training | Self Rate of Perceived Exertion (RPE) will be assessed via OMNI RES Scale (0-10 values) during resistance training (after every circuit) and 15-20 minutes after finishing each session. | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Blood Cells count | White blood cell (WBC) count including a five-part differential. | Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Supplement, Protein, Resistance Training, Pre-workout, Strength, Rate of Perceived Exertion, Muscle