Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing

Fatigue Clinical Trial

Official title:

Effects of a Protein-Based Multi-Ingredient Recovery Supplement Combined With Resistance Training on Body Composition, Performance, Muscular Properties, and Wellbeing on Middle-Aged and Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769101
• Other study ID #: UGreenwich4
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 1, 2022

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, post-workout supplement (REC) 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 immediately (within 15 min) after 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: Completed
• Enrollment: 20
• Est. completion date: June 1, 2022
• Est. primary completion date: May 30, 2022
• 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 Post-Workout Supplement
The Post-Workout Supplement is administered 15 minutes after the completion 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 after the completion 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	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	Distance (measured in centimetres)	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).	[Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]
Primary	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