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

Fatigue Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05769088
• Other study ID #: UGreenwich3
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: March 2023
• Source: University of Greenwich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.).

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Joel Puente	Crown Sport Nutrition, Go Fit Spain

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vertical Jump	Height (measured in centimetres)	Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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