- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769101
Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Avery Hill, London.
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London, Avery Hill, London., United Kingdom, SE9 2BT
- University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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Placebo Comparator: Maltodextrin Supplement
An isoenergetic Maltodextrin supplement will be administered as placebo.
Dissolved in 350 ml of water.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vertical Jump
Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Height (measured in centimetres)
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Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Muscle Thickness
Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs
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Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Chest Medicine Ball Throw
Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Distance (measured in centimetres)
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Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Self Perceived Energy Feeling
Time Frame: [Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]
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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).
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[Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]
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White Blood Cells count
Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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White blood cell (WBC) count including a five-part differential
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Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGreenwich4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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