Protein DeficiencyNCT05769088
Effects of a Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing in Adults.
A study testing Ingestion of a Pre-Workout Supplement and Ingestion of a Maltodextrin Supplement in people with Protein Deficiency and Training Group, Sensitivity, run by Joel Puente at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Deficiency, Training Group, Sensitivity, Fatigue
- What is being tested?
- Ingestion of a Pre-Workout Supplement and Ingestion of a Maltodextrin Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (no injuries, illnesses or medication intake).
- Between 45 and 65 years old.
- Active and familiarised with Resistance Training.
Who cannot join
- Unhealthy (illnesses or medication intake) or injured.
- Untrained.
- Young (<45 y.o.) or elderly (>65 y.o.).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
London, Avery Hill, London., SE9 2BT
About this study
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.
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.
Read the 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.
- Being tested
- Ingestion of a Pre-Workout Supplement, Ingestion of a Maltodextrin Supplement
- Keywords
- Fatigue, Supplement, Protein, Resistance Training, Pre-workout, Strength, Rate of Perceived Exertion, Muscle
- Medical subject headings
- Protein Deficiency, Hypersensitivity, Fatigue, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of a Pre-Workout SupplementDietary 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 SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Ingredient Pre-Workout Supplement | Experimental | 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. Receives: Dietary Supplement: Ingestion of a Pre-Workout Supplement |
| Maltodextrin Supplement | Placebo comparator | A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water. Receives: Dietary Supplement: Ingestion of a Maltodextrin Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Vertical Jump
Height (measured in centimetres)
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Chest Medicine Ball Throw
Medicine Ball Throw (measured in meters and centimetres).
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Maximal Mid-Thigh Pull Isometric Strength
Maximal Strength (measured in kilograms).
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Muscle Thickness
Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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).
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
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.
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Secondary outcomes (1)
White Blood Cells count
White blood cell (WBC) count including a five-part differential.
Measured: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joel Puente
- Sponsor type
- University, hospital or other
- Collaborators
- Crown Sport Nutrition, Go Fit Spain
- Responsible party
- Sponsor-investigator, Joel Puente, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769088
- Sponsor's protocol ID
- UGreenwich3
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puente-Fernandez J, Larumbe-Zabala E, Roberts J, Naclerio F. Effect of a Multi-Ingredient Post-Workout Dietary Supplement on Body Composition and Muscle Strength - A Randomized Controlled Trial. J Diet Suppl. 2025;22(3):445-462. doi: 10.1080/19390211.2025.2488811. Epub 2025 Apr 12.
PubMed 40219860
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05769088
- Acronym / sponsor ID
- UGreenwich3
- Keywords
- Fatigue, Supplement, Protein, Resistance Training, Pre-workout, Strength, Rate of Perceived Exertion, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Joel PuenteUniversity, hospital or other
- Collaborators
- Crown Sport Nutrition, Go Fit Spain
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.
| Arm | Type | Receives |
|---|---|---|
| Multi-Ingredient Pre-Workout Supplement | Experimental | Dietary Supplement: Ingestion of a Pre-Workout SupplementA 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. |
| Maltodextrin Supplement | Placebo comparator | Dietary Supplement: Ingestion of a Maltodextrin SupplementA isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy (no injuries, illnesses or medication intake).
- Between 45 and 65 years old.
- Active and familiarised with Resistance Training.
Key exclusion criteria (3 listed)
- Unhealthy (illnesses or medication intake) or injured.
- Untrained.
- Young (<45 y.o.) or elderly (>65 y.o.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestion of a Pre-Workout SupplementThe 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. | Dietary supplement | Multi-Ingredient Pre-Workout Supplement |
| Ingestion of a Maltodextrin SupplementThe 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. | Dietary supplement | Maltodextrin Supplement |
Primary outcome
Tensiomyography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Whole Body Perceptual Response during Resistance Training
Time frame: 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.
1 secondary outcome
White Blood Cells count
Time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 40219860Puente-Fernandez J, Larumbe-Zabala E, Roberts J, Naclerio F. Effect of a Multi-Ingredient Post-Workout Dietary Supplement on Body Composition and Muscle Strength - A Randomized Controlled Trial. J Diet Suppl. 2025;22(3):445-462. doi: 10.1080/19390211.2025.2488811. Epub 2025 Apr 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestion of a Pre-Workout Supplement and Ingestion of a Maltodextrin Supplement in people with Protein Deficiency and Training Group, Sensitivity, run by Joel Puente at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tensiomyography (time frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.