Protein DeficiencyNCT04147741
Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults.
A study testing Pre-Workout Supplement, Resistance Training and Endurance Training in people with Protein Deficiency and Training Group, Sensitivity, run by University of Greenwich at 1 site in United Kingdom.
Trial summary
The investigation will be conducted as a double blinded, randomized, crossover within-participant comparison design with two 1-week intervention periods separated by 2-weeks for wash out, recovery, period. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Deficiency, Training Group, Sensitivity, Fatigue
- What is being tested?
- Pre-Workout Supplement, Resistance Training and Endurance Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2019to 21 Mar 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (no current injuries).
- Between 45 and 70 years old.
- Active.
Who cannot join
- Injuries.
- Never trained before.
- Under 45 or over 70 years old.
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 Multi-Ingredient Pre-Workout on Performance, Perceptual Responses, Subjective Feelings of Energy and Muscular Contractile Properties, After a Resistance and Endurance Training Microcycle in Older Participants.
The investigation will be conducted as a double blinded, randomized, crossover within-participant comparison design with two 1-week intervention periods separated by 2-weeks for wash out, recovery, period.
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 take a 5-day microcycle, involving three resistance training sessions (Monday, Wednesday and Friday) intercalated with two endurance training sessions (Tuesday and Thursday). After the first interventional microcycle, and the 2-week washout period, the participants will switch to the other nutritional condition for continuation with the second 5-day identical microcycle. Assessments of muscle contractile properties via Tensiomyography on Vastus Medialis, Biceps Femoris Long Head and Anterior Deltoids will be taken before and after each resistance training session. Measurements of strength (Isometric Mid Thigh Pull) upper and lower body muscular power (Medicine Ball Throw and Vertical Jump) will be performed immediately after each resistance training workout. The supplements will be ingested 15 min before each training session, just before completing an energy feeling questionnaire. In addition, the perceptual response to training will be assessed during and 20 min after the completion of all workouts. The contribution of carbohydrate and fat metabolism will be estimated using a gas analyzer via the calculation of respiratory exchange ratio the (RER) during each endurance training session.
- Being tested
- Pre-Workout Supplement, Resistance Training, Endurance Training
- Keywords
- Fatigue, Supplement, Pre-Workout, Muscle, Recovery, Training, Strength, Endurance, Perceptual Response
- 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.
Pre-Workout SupplementDietary supplement
Also called Multi-Ingredient Supplement
One week familiarisation, one-week training, two weeks washout period and one-week training.
15 Minutes before every training, the Pre-Workout Arm (PRE-W) will take a Supplement shake, consisting of some ingredients (Multi-Ingredient, explained before) and the Placebo Comparator Arm (CHO) will drink a Placebo shake, consisting of Maltodextrin.
Resistance TrainingOther
Also called Free Weights Training
-Resistance Training days (Monday-Wednesday-Friday): Before training starts, Tensiomyography and Energy Feeling will be assessed (Energy Level, Fatigue Level, Feeling of Alertness, and Feeling of Focus on the task). Immediately after finishing, Tensiomyography and Performance (Vertical Jump, Overhead Medicine Ball Throw, and Maximal Mid-Tigh Pull Isometric Strength) will be assessed. Training Protocol: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Parallel Squat; Bench Press; Alternate Box Set-Ups; Shoulder Press; Alternate Lunges; Up-right Row; Hip-Thrust; Squat on Isoinertial Fly-Wheel or Drop Jump). The participants will have to 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 will be added for the next set. Also, whole-body Perceptual Response will be assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.
Endurance TrainingOther
Also called Cycloergometer Training
- Endurance Training days (Tuesday-Thursday): Energy Feeling Questionnaire will be implemented before training. The training will consist of 30 minutes cycling at their Fatmax Intensity (~60% Vo2max) on a Cycloergometer (estimated during familiarisation week). Also, the Heart Rate will be recorded during the whole training. Besides, Perception of Effort will be assessed using the 6-20 version of the Borg Scale every 5 minutes during training and 15 minutes after it has been completed.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Workout Supplement | Experimental | A 60 g dose of a commercially available pre-workout 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 250 ml of water. Receives: Dietary Supplement: Pre-Workout Supplement; Other: Resistance Training; Other: Endurance Training |
| Maltodextrin Supplement | Placebo comparator | A isoenergetic Maltodextrin supplement will be administered as placebo. With 250 ml of water. Receives: Dietary Supplement: Pre-Workout Supplement; Other: Resistance Training; Other: Endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tensiomyography
Fatigue and contractility assessment via Tensiomyography will be assessed in Biceps Femoris Long Head, Vastus Medialis, and Anterior Deltoid.
Measured: Changes from 10 minutes Previous to post 1 hour after the completion of each workout session
Vertical Jump
Flight Time (measured in seconds).
Measured: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
Over Head Medicine Ball Throw
Medicine Ball Throw (measured in meters and centimeters).
Measured: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
Maximal Mid-Thigh Pull Isometrical Strength
Maximal Strength (measured in kilograms).
Measured: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
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: Before every Training Session and up to 1 week of training.
Secondary outcomes (2)
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: Differences between first week and second week of training.
Perception of Effort during Endurance Training.
Borg Scale (6-20) will be used to collect the perception of effort during endurance training (every 5 minutes) and 15-20 minutes after each session.
Measured: Differences between first week and second week of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start21 Oct 2019
- Primary completion21 Mar 2020
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- One week training (3 days Resistance Training and 2 Endurance Training in alternate days) with a Pre-Workout Supplement or Maltodextrin. 2 Weeks wash out period and then change supplement.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Collaborators
- Crown Sport Nutrition, Go Fit Spain
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Joel Puente, Principal investigator, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147741
- Sponsor's protocol ID
- UGreenwich
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-Ingredient Pre-Workout on Performance, Perceptual Responses, Subjective Feelings of Energy and Muscular Contractile Properties, After a Resistance and Endurance Training Microcycle in Older Participants.
- ClinicalTrials.gov ID
- NCT04147741
- Acronym / sponsor ID
- UGreenwich
- Keywords
- Fatigue, Supplement, Pre-Workout, Muscle, Recovery, Training, Strength, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Collaborators
- Crown Sport Nutrition, Go Fit Spain
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 1 Nov 2019 (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, crossover within-participant comparison design with two 1-week intervention periods separated by 2-weeks for wash out, recovery, period.
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 take a 5-day microcycle, involving three resistance training sessions (Monday, Wednesday and Friday) intercalated with two endurance training sessions (Tuesday and Thursday). After the first interventional microcycle, and the 2-week washout period, the participants will switch to the other nutritional condition for continuation with the second 5-day identical microcycle. Assessments of muscle contractile properties via Tensiomyography on Vastus Medialis, Biceps Femoris Long Head and Anterior Deltoids will be taken before and after each resistance training session. Measurements of strength (Isometric Mid Thigh Pull) upper and lower body muscular power (Medicine Ball Throw and Vertical Jump) will be performed immediately after each resistance training workout. The supplements will be ingested 15 min before each training session, just before completing an energy feeling questionnaire. In addition, the perceptual response to training will be assessed during and 20 min after the completion of all workouts. The contribution of carbohydrate and fat metabolism will be estimated using a gas analyzer via the calculation of respiratory exchange ratio the (RER) during each endurance training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One week training (3 days Resistance Training and 2 Endurance Training in alternate days) with a Pre-Workout Supplement or Maltodextrin. 2 Weeks wash out period and then change supplement.
| Arm | Type | Receives |
|---|---|---|
| Pre-Workout Supplement | Experimental | Dietary Supplement: Pre-Workout Supplement, Other: Resistance Training, Other: Endurance TrainingA 60 g dose of a commercially available pre-workout 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 250 ml of water. |
| Maltodextrin Supplement | Placebo comparator | Dietary Supplement: Pre-Workout Supplement, Other: Resistance Training, Other: Endurance TrainingA isoenergetic Maltodextrin supplement will be administered as placebo. With 250 ml of water. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy (no current injuries).
- Between 45 and 70 years old.
- Active.
Key exclusion criteria (3 listed)
- Injuries.
- Never trained before.
- Under 45 or over 70 years old.
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 |
|---|---|---|
| Pre-Workout SupplementAlso: Multi-Ingredient SupplementOne week familiarisation, one-week training, two weeks washout period and one-week training. 15 Minutes before every training, the Pre-Workout Arm (PRE-W) will take a Supplement shake, consisting of some ingredients (Multi-Ingredient, explained before) and the Placebo Comparator Arm (CHO) will drink a Placebo shake, consisting of Maltodextrin. | Dietary supplement | Maltodextrin Supplement, Pre-Workout Supplement |
| Resistance TrainingAlso: Free Weights Training-Resistance Training days (Monday-Wednesday-Friday): Before training starts, Tensiomyography and Energy Feeling will be assessed (Energy Level, Fatigue Level, Feeling of Alertness, and Feeling of Focus on the task). Immediately after finishing, Tensiomyography and Performance (Vertical Jump, Overhead Medicine Ball Throw, and Maximal Mid-Tigh Pull Isometric Strength) will be assessed. Training Protocol: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Parallel Squat; Bench Press; Alternate Box Set-Ups; Shoulder Press; Alternate Lunges; Up-right Row; Hip-Thrust; Squat on Isoinertial Fly-Wheel or Drop Jump). The participants will have to 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 will be added for the next set. Also, whole-body Perceptual Response will be assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing. | Other | Maltodextrin Supplement, Pre-Workout Supplement |
| Endurance TrainingAlso: Cycloergometer Training- Endurance Training days (Tuesday-Thursday): Energy Feeling Questionnaire will be implemented before training. The training will consist of 30 minutes cycling at their Fatmax Intensity (~60% Vo2max) on a Cycloergometer (estimated during familiarisation week). Also, the Heart Rate will be recorded during the whole training. Besides, Perception of Effort will be assessed using the 6-20 version of the Borg Scale every 5 minutes during training and 15 minutes after it has been completed. | Other | Maltodextrin Supplement, Pre-Workout Supplement |
Primary outcome
Tensiomyography
Time frame: Changes from 10 minutes Previous to post 1 hour after the completion of each workout session
Fatigue and contractility assessment via Tensiomyography will be assessed in Biceps Femoris Long Head, Vastus Medialis, and Anterior Deltoid.
Vertical Jump
Time frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
Flight Time (measured in seconds).
Over Head Medicine Ball Throw
Time frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
Medicine Ball Throw (measured in meters and centimeters).
Maximal Mid-Thigh Pull Isometrical Strength
Time frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session
Maximal Strength (measured in kilograms).
Self Perceived Energy Feeling
Time frame: Before every Training Session and up to 1 week of training.
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).
2 secondary outcomes
Whole Body Perceptual Response during Resistance Training
Time frame: Differences between first week and second week of training.
Perception of Effort during Endurance Training.
Time frame: Differences between first week and second week of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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.
Joel Puente principal investigator
University of Greenwich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Workout Supplement, Resistance Training and Endurance Training in people with Protein Deficiency and Training Group, Sensitivity, run by University of Greenwich 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: finished, as of the sponsor's last update on 3 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 10 minutes Previous to post 1 hour after the completion of each workout session). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.