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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue; Muscular Atrophy; Psychological; Protein Deficiency; Training Group, Sensitivity
• Intervention / Treatment: Dietary supplement: Ingestion of a Pre-Workout Supplement; Dietary supplement: Ingestion of a Maltodextrin Supplement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-Ingredient Pre-Workout Supplement; 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; 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.
Placebo Comparator: Maltodextrin Supplement; A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water.	Dietary supplement: Ingestion of a Maltodextrin Supplement; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Joel Puente
• Collaborators: Crown Sport Nutrition; Go Fit Spain

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2023
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Resistance Training; Protein; Strength; Muscle; Supplement; Rate of Perceived Exertion; Pre-workout
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Deficiency Diseases; Malnutrition; Atrophy; Fatigue; Muscular Atrophy; Protein Deficiency
• Other Study ID Numbers: UGreenwich3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No