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Clinical Trials/NCT05769088
NCT05769088Not yet recruitingNot Applicable

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.

Joel Puente1 site in 1 country40 target enrollmentStarted: March 15, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Chest Medicine Ball Throw

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.).

Arms & Interventions

Multi-Ingredient Pre-Workout Supplement

Experimental

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.

Intervention: Ingestion of a Pre-Workout Supplement (Dietary Supplement)

Maltodextrin Supplement

Placebo Comparator

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

Intervention: Ingestion of a Maltodextrin Supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Chest Medicine Ball Throw

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • White Blood Cells count(Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program)

Investigators

Sponsor
Joel Puente
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Joel Puente

Principal Investigator

University of Greenwich

Study Sites (1)

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