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

Sponsor

Joel Puente (Other)

Overall Status

Completed

CT.gov ID

NCT05769101

Collaborator

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

Enrollment

Location

Arms

3.9

Actual Duration (Months)

5.1

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 Post-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, 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

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

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multi-Ingredient Post-Workout Supplement A 60 g dose of a commercially available Recovery supplement providing ~205 kcal including Proteins (+EAA), Carbohydrates, Creatine, and Vitamin D. Diluted in 350 ml of water.	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.
Placebo Comparator: Maltodextrin Supplement An isoenergetic Maltodextrin supplement will be administered as placebo. Dissolved in 350 ml of water.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: Multi-Ingredient Post-Workout Supplement

A 60 g dose of a commercially available Recovery supplement providing ~205 kcal including Proteins (+EAA), Carbohydrates, Creatine, and Vitamin D. Diluted in 350 ml of water.

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.

Placebo Comparator: Maltodextrin Supplement

An isoenergetic Maltodextrin supplement will be administered as placebo. Dissolved in 350 ml of water.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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]
Distance (measured in centimetres)
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 [[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).
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