Dietary ModificationNCT02425020
Meat and Whey Protein Supplementation in Athletes
A study testing Meat Protein, Whey protein and Carbohydrate in people with Dietary Modification, run by University of Greenwich.
Trial summary
The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular resistance training programme on (a) body composition (b) performance (c) muscle structure (d) general markers health and immunity in athletes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Meat Protein, Whey protein and Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2015
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- regularly trained athletes,
- aged 18 to 45 years old,
- minimum 3 months of experience in resistance training exercise,
- volunteers,
Who cannot join
- any musculoskeletal injuries, metabolic conditions, or diseases;
- use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.
About this study
Official title: Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure and Markers of Muscle Damage and Health in Athletes
The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular resistance training programme on (a) body composition (b) performance (c) muscle structure (d) general markers health and immunity in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates meat protein extract compared to the ingestion of others commercially available protein sources such as whey or casein.
Read the detailed description
This investigation involves a 8 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates meat protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, markers of immunity and health after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (MEAT); 2) Whey (W) and 3) non-protein iso-energetic placebo (CHO). Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: MEAT; W and CHO. Each group will follow a 8-week periodised resistance training intervention combined with one of the three specific supplementation treatments (MEAT, W or CHO). Measurements of general markers of health, immunity, body composition, muscle structure and performance will be determined before and after the training intervention.
Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance. 1) The meat protein group (MEAT n=10) that will take 250 ml of orange juice mixed with 20g of hydrolysates meat protein powder and water 2) The whey group (n=10) will take 20 g of whey intact isolate powder mixed with 250 ml of orange juice and water 3) the contrast group (P n=10) that will take an iso-energetic non-protein, only carbohydrate (maltodextrin) placebo.
Participants: Thirty participants, recruited from the University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.
Intervention Familiarization period: Participants will undertake 3 sessions of familiarization (1 weeks). A qualified strength and conditioning coach will control and assists participants in order to guarantee a correct execution of the selected exercise. All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (0-10) scale to control the load and training intensity.
Resistance Training: The resistance-training program will be designed to increase strength and mass of all major muscle groups. The program will be undertaken on three non-consecutive days per week, under the supervision of strength and conditioning coaches, preferable Strength and Conditioning master students. Training workout will be performed during the afternoon (between 3pm and 6pm) with at least 48 hours between sessions.
Each session will begin with individualized warm-up (5-minute warm-up stretches, followed by one set of eight repetitions of six resistance training exercises without any additional weight). Workout will involve 8 resistance exercises per 3 sets of 6 to 10 repetitions at 70% to 85% of an individual 1RM. Exercises will be performed using free-weights, elastic bands, sticks and machines selected to stress the major muscle groups. Resting periods of around 2 min will be allowed sets. Participants will be instructed to maintain the proper execution along the entire training session.
Periodization strategy: The intervention will consist of 8-week periodised resistance training programme that will be divided in 3 blocks: First block (1st to 3th week) using a moderate load intensity of around 70%1RM; Second block (4th to 6th week) where the intensity will increase to >75% to 80% 1RM and the third block (7th to 8th week) where the highest loads (>80 to 85% 1RM) will be used. The Rate of Perceive Exertion (0-10) scale (RPE) will be used to appropriately select the load along the training intervention. Resistance training intervention will be appropriately integrated with the regular sport activity performed by the University athletes along the academic period.
Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast. Supplements and placebo will be provided in powder form and should be mixed with an standardised orange juice and water at the moment of consumption. Supplements and placebo will looks and tastes identical.
Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 56 doses for a total of 8 weeks of study intervention.
Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.
- Conditions
- Dietary Modification
- Being tested
- Meat Protein, Whey protein, Carbohydrate
- Keywords
- Supplement, performance, whey, meat, protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meat ProteinDietary supplement
Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of meat protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
Whey proteinDietary supplement
Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of whey protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
CarbohydrateDietary supplement
Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing about 20g of maltodextrin mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Meat protein | Experimental | Post workout (training days) or breakfast (non training days) 20g of meat protein mixed with 250ml of orange juice and water Receives: Dietary Supplement: Meat Protein |
| Whey Protein | Experimental | Post workout (training days) or breakfast (non training days) 20g of whey protein isolate mixed with 250ml of orange juice and water Receives: Dietary Supplement: Whey protein |
| Carbohydrate | Active comparator | Post workout (training days) or breakfast (non training days) maltodextrin mixed with 250ml orange juice and water Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fat Free mass and Fat Mass.
Measured: 8 weeks
Secondary outcomes (14)
Muscle Structure
Thickness of biceps brachialis short head and vastus lateralis
Measured: 8 weeks
Muscle damage marker
Creatine Kinase (CK)
Measured: 8 weeks
Analysis of glycaemia
Measured: 8 weeks
Analysis of total cholesterol
Measured: 8 weeks
Analysis of HDL, cholesterol
Measured: 8 weeks
Analysis of LDL,cholesterol
Measured: 8 weeks
Analysis of Aspartate amino transferase
Measured: 8 weeks
Analysis of Alanine amino transferase
Measured: Pre and post 8 weeks intervention programme
Analysis of Triglycerides
Measured: 8 weeks
Analysis of Urea
Measured: 8 weeks
Analysis of Uric acid
Measured: 8 weeks
Immune system (Analysis of Antimicrobial peptides)
Antimicrobial peptides
Measured: 8 weeks
Maximal Strength performance
1RM bench press and 1 RM squat
Measured: 8 weeks
Power performance (jump test on force plate and maximal power at 50% 1RM bench press)
jump test on force plate and maximal power at 50% 1RM bench press
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Fernando Naclerio, PhD, Principal investigator, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425020
- Sponsor's protocol ID
- uREC0015
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure and Markers of Muscle Damage and Health in Athletes
- ClinicalTrials.gov ID
- NCT02425020
- Acronym / sponsor ID
- uREC0015
- Conditions
- Dietary Modification
- Keywords
- Supplement, performance, whey, meat, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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 aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular resistance training programme on (a) body composition (b) performance (c) muscle structure (d) general markers health and immunity in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates meat protein extract compared to the ingestion of others commercially available protein sources such as whey or casein.
Detailed description
This investigation involves a 8 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates meat protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, markers of immunity and health after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (MEAT); 2) Whey (W) and 3) non-protein iso-energetic placebo (CHO). Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: MEAT; W and CHO. Each group will follow a 8-week periodised resistance training intervention combined with one of the three specific supplementation treatments (MEAT, W or CHO). Measurements of general markers of health, immunity, body composition, muscle structure and performance will be determined before and after the training intervention.
Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance. 1) The meat protein group (MEAT n=10) that will take 250 ml of orange juice mixed with 20g of hydrolysates meat protein powder and water 2) The whey group (n=10) will take 20 g of whey intact isolate powder mixed with 250 ml of orange juice and water 3) the contrast group (P n=10) that will take an iso-energetic non-protein, only carbohydrate (maltodextrin) placebo.
Participants: Thirty participants, recruited from the University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.
Intervention Familiarization period: Participants will undertake 3 sessions of familiarization (1 weeks). A qualified strength and conditioning coach will control and assists participants in order to guarantee a correct execution of the selected exercise. All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (0-10) scale to control the load and training intensity.
Resistance Training: The resistance-training program will be designed to increase strength and mass of all major muscle groups. The program will be undertaken on three non-consecutive days per week, under the supervision of strength and conditioning coaches, preferable Strength and Conditioning master students. Training workout will be performed during the afternoon (between 3pm and 6pm) with at least 48 hours between sessions.
Each session will begin with individualized warm-up (5-minute warm-up stretches, followed by one set of eight repetitions of six resistance training exercises without any additional weight). Workout will involve 8 resistance exercises per 3 sets of 6 to 10 repetitions at 70% to 85% of an individual 1RM. Exercises will be performed using free-weights, elastic bands, sticks and machines selected to stress the major muscle groups. Resting periods of around 2 min will be allowed sets. Participants will be instructed to maintain the proper execution along the entire training session.
Periodization strategy: The intervention will consist of 8-week periodised resistance training programme that will be divided in 3 blocks: First block (1st to 3th week) using a moderate load intensity of around 70%1RM; Second block (4th to 6th week) where the intensity will increase to >75% to 80% 1RM and the third block (7th to 8th week) where the highest loads (>80 to 85% 1RM) will be used. The Rate of Perceive Exertion (0-10) scale (RPE) will be used to appropriately select the load along the training intervention. Resistance training intervention will be appropriately integrated with the regular sport activity performed by the University athletes along the academic period.
Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast. Supplements and placebo will be provided in powder form and should be mixed with an standardised orange juice and water at the moment of consumption. Supplements and placebo will looks and tastes identical.
Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 56 doses for a total of 8 weeks of study intervention.
Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meat protein | Experimental | Dietary Supplement: Meat ProteinPost workout (training days) or breakfast (non training days) 20g of meat protein mixed with 250ml of orange juice and water |
| Whey Protein | Experimental | Dietary Supplement: Whey proteinPost workout (training days) or breakfast (non training days) 20g of whey protein isolate mixed with 250ml of orange juice and water |
| Carbohydrate | Active comparator | Dietary Supplement: CarbohydratePost workout (training days) or breakfast (non training days) maltodextrin mixed with 250ml orange juice and water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regularly trained athletes,
- aged 18 to 45 years old,
- minimum 3 months of experience in resistance training exercise,
- volunteers,
Key exclusion criteria (2 listed)
- any musculoskeletal injuries, metabolic conditions, or diseases;
- use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.
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 |
|---|---|---|
| Meat ProteinImmediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of meat protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast. | Dietary supplement | Meat protein |
| Whey proteinImmediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of whey protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast. | Dietary supplement | Whey Protein |
| CarbohydrateImmediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing about 20g of maltodextrin mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast. | Dietary supplement | Carbohydrate |
Primary outcome
Body composition
Time frame: 8 weeks
Fat Free mass and Fat Mass.
14 secondary outcomes
Muscle Structure
Time frame: 8 weeks
Muscle damage marker
Time frame: 8 weeks
Analysis of glycaemia
Time frame: 8 weeks
Analysis of total cholesterol
Time frame: 8 weeks
Analysis of HDL, cholesterol
Time frame: 8 weeks
Analysis of LDL,cholesterol
Time frame: 8 weeks
Analysis of Aspartate amino transferase
Time frame: 8 weeks
Analysis of Alanine amino transferase
Time frame: Pre and post 8 weeks intervention programme
Analysis of Triglycerides
Time frame: 8 weeks
Analysis of Urea
Time frame: 8 weeks
Analysis of Uric acid
Time frame: 8 weeks
Immune system (Analysis of Antimicrobial peptides)
Time frame: 8 weeks
Maximal Strength performance
Time frame: 8 weeks
Power performance (jump test on force plate and maximal power at 50% 1RM bench press)
Time frame: 8 weeks
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 23 Apr 2015.
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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 Naclerio, PhD principal investigator
University of Greenwich
Questions about this trial
What is this clinical trial studying?
A study testing Meat Protein, Whey protein and Carbohydrate in people with Dietary Modification, run by University of Greenwich.
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 4 inclusion and 2 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Body composition (time frame: 8 weeks). 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 23 Apr 2015.