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

NCT ID: NCT05769088

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-05-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ingestion of a Pre-Workout Supplement

Intervention Type: DIETARY_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.

Maltodextrin Supplement

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

Group Type: PLACEBO_COMPARATOR

Ingestion of a Maltodextrin Supplement

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crown Sport Nutrition

INDUSTRY

Sponsor Role: collaborator

Go Fit Spain

UNKNOWN

Sponsor Role: collaborator

Joel Puente

OTHER

Sponsor Role: lead

Responsible Party

Joel Puente

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

London, Avery Hill, London., United Kingdom

Countries

United Kingdom

References

Puente-Fernandez J, Larumbe-Zabala E, Roberts J, Naclerio F. Effect of a Multi-Ingredient Post-Workout Dietary Supplement on Body Composition and Muscle Strength - A Randomized Controlled Trial. J Diet Suppl. 2025;22(3):445-462. doi: 10.1080/19390211.2025.2488811. Epub 2025 Apr 12.

Reference Type: DERIVED

PMID: 40219860 (View on PubMed)

Other Identifiers

UGreenwich3

Identifier Type: -

Identifier Source: org_study_id