Muscle LossNCT04630977
Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)
A study testing Multi-ingredient Pre-workout supplement, Progressive Resistance Training and Nutritional Patterns Guideline in people with Muscle Loss and Obesity, run by University of Greenwich at 1 site in United Kingdom.
Trial summary
The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss, Obesity, Obesity, Abdominal
- What is being tested?
- Multi-ingredient Pre-workout supplement, Progressive Resistance Training and Nutritional Patterns Guideline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 28 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults (no current injuries or illnesses which may interfere with the project).
- Recreationally active adults (a minimum of 3 and a maximum of 5 days of training sessions per week: combining resistance and endurance).
Who cannot join
- Participants younger than 40 or older than 70 years old.
- Participants with hard injuries, disabilities or pathologies.
- People taking medication or other supplements which may interfere with the multi-ingredient pre-workout or the training sessions.
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
The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.
Read the detailed description
The methodology will follow a Home-based, online, double-blinded, randomised, long-term design. The participants recruited will be active, middle-aged and older healthy adults. The supplement intake will be a Pre-workout supplement intake or a placebo intake. The exercise training will be a Progressive Resistance Training, with sessions of ~1 hour (3 times/week). The intervention will last for a minimum of one year and the possibility to prolong it to another one (two years of intervention) if the adherence to the treatment was higher to the 75% of the participants (of, at least, 85% of the training sessions and supplementation intake).
The outcomes that will be assessed are: Body composition (fat mass and fat-free mass), physical performance (short test designed by Go Fit Lab: single-leg standing balance, upper-body strength - maximum number of push-ups repetitions in 15 seconds -, lower-body mechanical power - vertical jump -, agility/velocity - 30 seconds of static running at maximum velocity -, recovery assessment - 60 seconds monitoring of heart rate after the previous test -), Happiness Score (designed by Go Fit, including different self-reported validated tests, such as: Par-Q+, ACSM Cardiovascular Risk Factors Questionnaire, SF-12 for quality of life and self-perceived health status, PSS-4 Stress and mental health, Pittsburgh Sleeping Quality test, PREDIMED test: adherence to Mediterranean diet eating patterns, and the IPAQ short form), and for every workout: Self-perceived energy feeling (Questionnaire: Energy Level, Fatigue, Alertness and Focus for the Task), Rate of Perceived Exertion (OMNI RES Scale and Borg Scale) and adherence to regular physical exercise practise, healthy nutritional patterns, and supplement intake.
- Conditions
- Muscle Loss, Obesity, Obesity, Abdominal, Weight Loss, Happiness, Quality of Life
- Being tested
- Multi-ingredient Pre-workout supplement, Progressive Resistance Training, Nutritional Patterns Guideline
- Keywords
- Weight Loss, Body Composition, Home-Based, Supplement, Multi-ingredient
- Medical subject headings
- Muscular Atrophy, Obesity, Obesity, Abdominal, Weight Loss, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-ingredient Pre-workout supplementDietary supplement
Also called Preworkout
Every important issue has been detailed before.
Progressive Resistance TrainingOther
Also called PRT, RT
The information about it has been detailed in advance.
Nutritional Patterns GuidelineBehavioural
Also called Nutrition, Healthy Eating
This intervention has also been described in advance.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Ingredient Pre-workout Supplement | Experimental | This group of participants will intake a multi-ingredient supplement around ~15 minutes before every workout.
The nutritional information of the supplement is: ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine: 2.5g, L-arginine AKG: 2.5g, L-Leucine: 800mg, Taurine: 500mg, L-citrulline: 500mg- 6.8 g, Creatine monohydrate: 2.0g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg.
They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).
Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.
The training sessions and the nutritional guideline will be the same for the three groups. Receives: Dietary Supplement: Multi-ingredient Pre-workout supplement; Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline |
| Isocaloric Placebo | Active comparator | This group of participants will intake an isocaloric (only carbohydrates: Maltodextrin) supplement comparator, around ~15 minutes before every workout.
The nutritional information of the supplement is: ~90 Kcal. for 23g of powder.
They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).
Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.
The training sessions and the nutritional guideline will be the same for the three groups. Receives: Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline |
| Control | Sham comparator | These participants will drink a non-caloric admixture with the same taste, texture and flavour.
They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises).
Also, they will receive a specific guideline with simple tips to improve their nutritional patterns.
The training sessions and the nutritional guideline will be the same for the three groups. Receives: Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Mass
Assessment of the total adipose tissue via Bioelectrical Impedance.
Measured: Through study completion, an average of 1 year.
Fat-free Mass
Assessment of the total lean mass via Bioelectrical Impedance.
Measured: Through study completion, an average of 1 year.
Health Perception questionnaire
Short Form of 12 questions.
Higher scores mean better outcomes (score from 0 to 100).
Measured: 6 weeks.
Pittsburgh Sleep Quality Index
Short Form of 4 questions.
Higher scores mean better outcomes (score from 1 to 5).
Measured: 6 weeks.
Stress Level and Mental Health
Short Form of 4 questions.
Higher scores mean worse outcomes (score from 1 to 5).
Measured: 6 weeks.
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Short Form of 4 questions.
Higher scores mean better outcomes (score from 1 to 5).
Measured: 6 weeks.
International Physical Activity Questionnaire
7 questions.
Higher scores mean better outcomes (score from 1 to 5).
Measured: 6 weeks.
Single-Leg balance
Standing in one leg only, be capable of holding the position for 15 seconds. Performed with the dominant leg at first and the non-dominant leg afterwards.
Score from 1 to 15 (higher scores mean better outcomes).
Measured: 6 Weeks
Upper-Body push strength
Number of push-ups in 15 seconds.
The score will be the number of Push-Ups performed (higher scores mean better outcomes).
Measured: 6 Weeks
Lower-body mechanical power
Jump height with countermovement.
The jump will be performed from a standing position, lateral to the wall and jumping to touch the wall as high as possible (with chalk in their finger-prints to mark the height they touched the wall).
The score will be the height of the jump (higher scores mean better outcomes).
Measured: 6 Weeks
Recovery
Static running in 1m2 square as fast as possible for 30 seconds and immediately after, Heart Rate will be monitored for 1 minute
The score will be the difference from the Maximum Heart Rate minus the Heart Rate after 1 minute recovery (higher scores mean better outcomes).
Measured: 6 Weeks
Secondary outcomes (1)
Adherence to the treatment (regular training, supplement intake and healthy eating)
The compliance with the training and supplementation protocols will be measured constantly, as well as the healthy eating patterns. Those participants who have spent 7 days or more in a row without training or taking the supplement, as well as a final accomplishment of the 85% will be discarded from the final analysis.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jan 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion28 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies 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
- One group will intake a pre-workout multi-ingredient supplement. The second group will intake an isocaloric placebo containing only carbohydrates. The third group (control) will take a non-caloric placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Collaborators
- Ingesport Health Spa Consulting
- Responsible party
- Principal investigator, Joel Puente, University of Greenwich
- Investigators
- Fernando J Naclerio, Dr, Study director, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630977
- Sponsor's protocol ID
- UGreenwich2
- Status last verified
- Dec 2021
- First submitted
- 8 Nov 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)
- ClinicalTrials.gov ID
- NCT04630977
- Acronym / sponsor ID
- UGreenwich2
- Conditions
- Muscle Loss, Obesity, Obesity, Abdominal, Weight Loss, Happiness, Quality of Life
- Keywords
- Weight Loss, Body Composition, Home-Based, Supplement, Multi-ingredient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Collaborators
- Ingesport Health Spa Consulting
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 28 May 2023 (estimated)
- First posted
- 16 Nov 2020 (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 purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.
Detailed description
The methodology will follow a Home-based, online, double-blinded, randomised, long-term design. The participants recruited will be active, middle-aged and older healthy adults. The supplement intake will be a Pre-workout supplement intake or a placebo intake. The exercise training will be a Progressive Resistance Training, with sessions of ~1 hour (3 times/week). The intervention will last for a minimum of one year and the possibility to prolong it to another one (two years of intervention) if the adherence to the treatment was higher to the 75% of the participants (of, at least, 85% of the training sessions and supplementation intake).
The outcomes that will be assessed are: Body composition (fat mass and fat-free mass), physical performance (short test designed by Go Fit Lab: single-leg standing balance, upper-body strength - maximum number of push-ups repetitions in 15 seconds -, lower-body mechanical power - vertical jump -, agility/velocity - 30 seconds of static running at maximum velocity -, recovery assessment - 60 seconds monitoring of heart rate after the previous test -), Happiness Score (designed by Go Fit, including different self-reported validated tests, such as: Par-Q+, ACSM Cardiovascular Risk Factors Questionnaire, SF-12 for quality of life and self-perceived health status, PSS-4 Stress and mental health, Pittsburgh Sleeping Quality test, PREDIMED test: adherence to Mediterranean diet eating patterns, and the IPAQ short form), and for every workout: Self-perceived energy feeling (Questionnaire: Energy Level, Fatigue, Alertness and Focus for the Task), Rate of Perceived Exertion (OMNI RES Scale and Borg Scale) and adherence to regular physical exercise practise, healthy nutritional patterns, and supplement intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- One group will intake a pre-workout multi-ingredient supplement. The second group will intake an isocaloric placebo containing only carbohydrates. The third group (control) will take a non-caloric placebo.
| Arm | Type | Receives |
|---|---|---|
| Multi-Ingredient Pre-workout Supplement | Experimental | Dietary Supplement: Multi-ingredient Pre-workout supplement, Other: Progressive Resistance Training, Behavioral: Nutritional Patterns GuidelineThis group of participants will intake a multi-ingredient supplement around ~15 minutes before every workout. The nutritional information of the supplement is: ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine: 2.5g, L-arginine AKG: 2.5g, L-Leucine: 800mg, Taurine: 500mg, L-citrulline: 500mg- 6.8 g, Creatine monohydrate: 2.0g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
| Isocaloric Placebo | Active comparator | Other: Progressive Resistance Training, Behavioral: Nutritional Patterns GuidelineThis group of participants will intake an isocaloric (only carbohydrates: Maltodextrin) supplement comparator, around ~15 minutes before every workout. The nutritional information of the supplement is: ~90 Kcal. for 23g of powder. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
| Control | Sham comparator | Other: Progressive Resistance Training, Behavioral: Nutritional Patterns GuidelineThese participants will drink a non-caloric admixture with the same taste, texture and flavour. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults (no current injuries or illnesses which may interfere with the project).
- Recreationally active adults (a minimum of 3 and a maximum of 5 days of training sessions per week: combining resistance and endurance).
Key exclusion criteria (3 listed)
- Participants younger than 40 or older than 70 years old.
- Participants with hard injuries, disabilities or pathologies.
- People taking medication or other supplements which may interfere with the multi-ingredient pre-workout or the training sessions.
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 |
|---|---|---|
| Multi-ingredient Pre-workout supplementAlso: PreworkoutEvery important issue has been detailed before. | Dietary supplement | Multi-Ingredient Pre-workout Supplement |
| Progressive Resistance TrainingAlso: PRT, RTThe information about it has been detailed in advance. | Other | Control, Isocaloric Placebo, Multi-Ingredient Pre-workout Supplement |
| Nutritional Patterns GuidelineAlso: Nutrition, Healthy EatingThis intervention has also been described in advance. | Behavioural | Control, Isocaloric Placebo, Multi-Ingredient Pre-workout Supplement |
Primary outcome
Fat Mass
Time frame: Through study completion, an average of 1 year.
Assessment of the total adipose tissue via Bioelectrical Impedance.
Fat-free Mass
Time frame: Through study completion, an average of 1 year.
Assessment of the total lean mass via Bioelectrical Impedance.
Health Perception questionnaire
Time frame: 6 weeks.
Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100).
Pittsburgh Sleep Quality Index
Time frame: 6 weeks.
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
Stress Level and Mental Health
Time frame: 6 weeks.
Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5).
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Time frame: 6 weeks.
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
International Physical Activity Questionnaire
Time frame: 6 weeks.
7 questions. Higher scores mean better outcomes (score from 1 to 5).
Single-Leg balance
Time frame: 6 Weeks
Standing in one leg only, be capable of holding the position for 15 seconds. Performed with the dominant leg at first and the non-dominant leg afterwards. Score from 1 to 15 (higher scores mean better outcomes).
Upper-Body push strength
Time frame: 6 Weeks
Number of push-ups in 15 seconds. The score will be the number of Push-Ups performed (higher scores mean better outcomes).
Lower-body mechanical power
Time frame: 6 Weeks
Jump height with countermovement. The jump will be performed from a standing position, lateral to the wall and jumping to touch the wall as high as possible (with chalk in their finger-prints to mark the height they touched the wall). The score will be the height of the jump (higher scores mean better outcomes).
Recovery
Time frame: 6 Weeks
Static running in 1m2 square as fast as possible for 30 seconds and immediately after, Heart Rate will be monitored for 1 minute The score will be the difference from the Maximum Heart Rate minus the Heart Rate after 1 minute recovery (higher scores mean better outcomes).
1 secondary outcome
Adherence to the treatment (regular training, supplement intake and healthy eating)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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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.
Fernando J Naclerio, Dr study director
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 Multi-ingredient Pre-workout supplement, Progressive Resistance Training and Nutritional Patterns Guideline in people with Muscle Loss and Obesity, 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 2 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 Dec 2021. 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?
Contact Joel Puente Fernández, PhD Student (+34626610821, jp2979a@gre.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Mass (time frame: Through study completion, an average of 1 year.). The study lists 11 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 15 Dec 2021.