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

Not Applicable

Not yet recruiting

• Conditions: Protein Deficiency; Fatigue; Training Group, Sensitivity; Muscular Atrophy; Psychological

• Registration Number: NCT05769088
• Lead Sponsor: Joel Puente

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.

Study Timeline

• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study Start: 2023-03-15
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chest Medicine Ball Throw	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	Medicine Ball Throw (measured in meters and centimetres).
Tensiomyography	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	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).
Muscle Thickness	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs
Vertical Jump	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	Height (measured in centimetres)
Maximal Mid-Thigh Pull Isometric Strength	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	Maximal Strength (measured in kilograms).
Whole Body Perceptual Response during Resistance Training	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	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.
Self Perceived Energy Feeling	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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