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

Sponsor

Joel Puente (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05769088

Collaborator

Crown Sport Nutrition (Other), Go Fit Spain (Other)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Deficiency Training Group, Sensitivity Fatigue Muscular Atrophy Psychological	Dietary Supplement: Ingestion of a Pre-Workout Supplement Dietary Supplement: Ingestion of a Maltodextrin Supplement	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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).
Vertical Jump [Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]
Height (measured in centimetres)
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).
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).
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
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).
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT	London	Avery Hill, London.	United Kingdom	SE9 2BT