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

Primary Purpose

Protein Deficiency, Training Group, Sensitivity, Fatigue

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ingestion of a Pre-Workout Supplement
Ingestion of a Maltodextrin Supplement
Sponsored by
Joel Puente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein Deficiency focused on measuring Fatigue, Supplement, Protein, Resistance Training, Pre-workout, Strength, Rate of Perceived Exertion, Muscle

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Multi-Ingredient Pre-Workout Supplement

Maltodextrin Supplement

Arm Description

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.

A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water.

Outcomes

Primary Outcome Measures

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).
Vertical Jump
Height (measured in centimetres)
Chest Medicine Ball Throw
Medicine Ball Throw (measured in meters and centimetres).
Maximal Mid-Thigh Pull Isometric Strength
Maximal Strength (measured in kilograms).
Muscle Thickness
Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs
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).
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.

Secondary Outcome Measures

White Blood Cells count
White blood cell (WBC) count including a five-part differential.

Full Information

First Posted
February 20, 2023
Last Updated
March 2, 2023
Sponsor
Joel Puente
Collaborators
Crown Sport Nutrition, Go Fit Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05769088
Brief Title
Effects of a Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing in Adults.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joel Puente
Collaborators
Crown Sport Nutrition, Go Fit Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Deficiency, Training Group, Sensitivity, Fatigue, Muscular Atrophy, Psychological
Keywords
Fatigue, Supplement, Protein, Resistance Training, Pre-workout, Strength, Rate of Perceived Exertion, Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Ingredient Pre-Workout Supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Maltodextrin Supplement
Arm Type
Placebo Comparator
Arm Description
A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ingestion of a Pre-Workout Supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ingestion of a Maltodextrin Supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tensiomyography
Description
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).
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Vertical Jump
Description
Height (measured in centimetres)
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Chest Medicine Ball Throw
Description
Medicine Ball Throw (measured in meters and centimetres).
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Maximal Mid-Thigh Pull Isometric Strength
Description
Maximal Strength (measured in kilograms).
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Muscle Thickness
Description
Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Self Perceived Energy Feeling
Description
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).
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Title
Whole Body Perceptual Response during Resistance Training
Description
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.
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Secondary Outcome Measure Information:
Title
White Blood Cells count
Description
White blood cell (WBC) count including a five-part differential.
Time Frame
Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.).
Facility Information:
Facility Name
University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
City
London
State/Province
Avery Hill, London.
ZIP/Postal Code
SE9 2BT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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