Dietary ModificationNCT02954367
Meat and Whey Protein Supplementation in Endurance Athletes
A study testing PROTEIN and CARBOHYDRATE in people with Dietary Modification, run by Universidad Europea de Madrid.
Trial summary
The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological markers in endurance 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?
- PROTEIN and CARBOHYDRATE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2017
- 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
- 18 years to 45
- Vo2max >50ml/kg/min
- Regularly trained athletes,
- Minimum 3 years 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, Immunological, Microbiota and Haematological Markers in Endurance Athletes
The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological markers in endurance athletes
Read the detailed description
PROYECT DESIGN This investigation involves a 10-week randomised, balanced, double blind parallel group between-subjects design, aimed to analyse the effects of combining endurance exercise and a post exercise nutrition strategy (hydrolysates meat protein (MEAT) + whey protein (W) or a isocaloric only carbohydrate placebo) on training outcomes, immunity and haematological variables after regular training and feeding intervention.
Participants will be divided in two-treatment groups 1) Hydrolysed meat-protein + whey (PROT); and 2) non-protein iso-energetic placebo (CHO). Once considered eligible for the study, and after an initial familiarisation period plus baseline tests (endurance performance body composition and blood extractions) participants will be randomly assigned to one of the intervention groups: PROT and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the two specific supplementation treatments (PROT or CHO). Measurements of performance (VO2peak, vetilatory threshold and time to exhaustion at maximal aerobic intensity), body composition (fat and fat free mass), microbiota and haematology will be determined before and after the 10-week intervention period.
Once informed consent and health history have been obtained, after the baseline assessment (t1), participants will be divided into two similar profile groups, matched by body mass, age, sex and maximal oxygen uptake (VO2peak): (1) PROT (2) CHO
INTERVENTION The intervention will comprise of a 10-week combined supplementation (MEAT + W and CHO) regular endurance-training programme.
Endurance training Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [< the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax]. Participants will train 5 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.
Cardiorespiratory test Participants will perform a maximal cardiorespiratory exercise test before the training period to determine peak oxygen uptake (VO2peak) and ventilatory thresholds. Percentage of HRmax and the 15 points (6 to 20) Borg Scale Rate of Perceive Exertion (RPE) will be used to appropriately select the load along the training intervention.
Supplementation protocol Training days: Immediately (<10 min) after completing each training session, participants will consume a beverage containing 20g of supplement (10g MEAT + 10g W) plus 200 ml of orange juice or only carbohydrate placebo (maltodextrine and orange juice).
Non-training days: before breakfast.
Supplements and placebo will be provided in powder form and should be mixed with 200ml of orange juice and water at the moment of consumption.
The supplements and placebo will look and taste identical.
Thus a total of one 20g doses will be administered on a daily base. Participants are required to ingest a total of 70 for the total of 10 weeks of the study intervention.
Supplements will be provided in 14 days intervals and distributed by a blinded researcher after participants return the empty bag of the supplement/placebo consumed during the previous 14 day period.
- Conditions
- Dietary Modification
- Being tested
- PROTEIN, CARBOHYDRATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTEINDietary supplement
Also called 100% BEEF
Immediately (<10 min) after completing each training session (resistance training) participants will consume a beverage containing 20g of meat protein (10g) plus whey (10g) mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
CARBOHYDRATEDietary supplement
Also called Maltodextrin
Immediately (<10 min) after completing each training session (resistance training), participants will consume a beverage containing about 20g of maltodextrin mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| PROTEIN (MEAT + WHEY) | Experimental | Post workout (training days) or breakfast (non training days) 20g of meat protein (10g meat + 10g whey) mixed with 200ml of orange juice and water Receives: Dietary Supplement: PROTEIN |
| CARBOHYDRATE (CHO) | Placebo comparator | Post workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml 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.
% Fat Mass (Body composition)
Estimated with Densitometry (DEXA)
Measured: 10 weeks
Visceral Adipose Tissue Mass (g) (Body composition)
Estimated with DEXA
Measured: 10 weeks
Total Fat Free mass (g) (Body composition)
Estimated with DEXA
Measured: 10 weeks
Bone mineral density (g/cm3) (Body composition)
Estimated with DEXA
Measured: 10 weeks
Secondary outcomes (22)
Blood Glucose (mg/dl)
Measured: 10 weeks
Creatine Kinase (Ul/l) -Blood markers-
Measured: 10 weeks
Creatinine (mg/dl) - Blood markers -
Measured: 10 weeks
Myoglobin (ng/ml) - Blood markers -
Measured: 10 weeks
Total cholesterol (mg/dl) -Blood markers-
Measured: 10 weeks
HDL cholesterol (mg/dl) -Blood markers-
Measured: 10 weeks
LDL cholesterol (mg/dl) -Blood markers-
Measured: 10 weeks
Aspartate amino transferasa (Ul/l) -Blood markers-
Measured: 10 weeks
Triglycerides (mg/dl) -Blood markers-
Measured: 10 weeks
Hemoglobin (g/dl) -Blood markers-
Measured: 10 weeks
Erythrocyte (M/µL) -Blood markers-
Measured: 10 weeks
Haematocrit (%) -Blood markers-
Measured: 10 weeks
Mean corpuscular volume (cubic millimeter)-Blood markers-
Measured: 10 weeks
Serum Transferrin (mg/dl) -Blood markers-
Measured: 10 weeks
Transferrin saturation (%) -Blood markers-
Measured: 10 weeks
Neutrophils (%) -Blood markers-
Measured: 10 weeks
Lymphocyte (%) -Blood markers-
Measured: 10 weeks
Monocytes (%) -Blood markers-
Measured: 10 weeks
Ferritin, serum (ng/ml) -Blood markers-
Measured: 10 weeks
Progressive maximal oxygen consumption test (Cardiorespiratory test)
- Maximum oxygen uptake (ml/kg/min)
Measured: 10 weeks
Time to exhaustion at maximal aerobic (min)
Measured: 10 weeks
Gut microbiota determination by 16S rRNA Sequencing
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (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 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- University of Greenwich
- Responsible party
- Principal investigator, DIEGO MORENO PÉREZ, Universidad Europea de Madrid
- Investigators
- DIEGO MORENO, PhD, Principal investigator, Universidad Europea de MadridFERNANDO NACLERIO, PhD, Principal investigator, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954367
- Sponsor's protocol ID
- BEEF-UEM-01
- Status last verified
- Nov 2016
- First submitted
- 19 Oct 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moreno-Perez D, Lopez-Samanes A, Larrosa M, Larumbe-Zabala E, Centeno A, Roberts J, Naclerio F. Effects of protein-carbohydrate vs. carbohydrate alone supplementation on immune inflammation markers in endurance athletes: a randomized controlled trial. Eur J Appl Physiol. 2023 Jul;123(7):1495-1505. doi: 10.1007/s00421-023-05168-6. Epub 2023 Mar 14.
PubMed 36918416
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meat Protein Administration on Body Composition, Strength, Immunological, Microbiota and Haematological Markers in Endurance Athletes
- ClinicalTrials.gov ID
- NCT02954367
- Acronym / sponsor ID
- BEEF-UEM-01
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- University of Greenwich
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 3 Nov 2016 (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 endurance training programme on (a) body composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological markers in endurance athletes
Detailed description
PROYECT DESIGN This investigation involves a 10-week randomised, balanced, double blind parallel group between-subjects design, aimed to analyse the effects of combining endurance exercise and a post exercise nutrition strategy (hydrolysates meat protein (MEAT) + whey protein (W) or a isocaloric only carbohydrate placebo) on training outcomes, immunity and haematological variables after regular training and feeding intervention.
Participants will be divided in two-treatment groups 1) Hydrolysed meat-protein + whey (PROT); and 2) non-protein iso-energetic placebo (CHO). Once considered eligible for the study, and after an initial familiarisation period plus baseline tests (endurance performance body composition and blood extractions) participants will be randomly assigned to one of the intervention groups: PROT and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the two specific supplementation treatments (PROT or CHO). Measurements of performance (VO2peak, vetilatory threshold and time to exhaustion at maximal aerobic intensity), body composition (fat and fat free mass), microbiota and haematology will be determined before and after the 10-week intervention period.
Once informed consent and health history have been obtained, after the baseline assessment (t1), participants will be divided into two similar profile groups, matched by body mass, age, sex and maximal oxygen uptake (VO2peak): (1) PROT (2) CHO
INTERVENTION The intervention will comprise of a 10-week combined supplementation (MEAT + W and CHO) regular endurance-training programme.
Endurance training Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [< the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax]. Participants will train 5 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.
Cardiorespiratory test Participants will perform a maximal cardiorespiratory exercise test before the training period to determine peak oxygen uptake (VO2peak) and ventilatory thresholds. Percentage of HRmax and the 15 points (6 to 20) Borg Scale Rate of Perceive Exertion (RPE) will be used to appropriately select the load along the training intervention.
Supplementation protocol Training days: Immediately (<10 min) after completing each training session, participants will consume a beverage containing 20g of supplement (10g MEAT + 10g W) plus 200 ml of orange juice or only carbohydrate placebo (maltodextrine and orange juice).
Non-training days: before breakfast.
Supplements and placebo will be provided in powder form and should be mixed with 200ml of orange juice and water at the moment of consumption.
The supplements and placebo will look and taste identical.
Thus a total of one 20g doses will be administered on a daily base. Participants are required to ingest a total of 70 for the total of 10 weeks of the study intervention.
Supplements will be provided in 14 days intervals and distributed by a blinded researcher after participants return the empty bag of the supplement/placebo consumed during the previous 14 day period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROTEIN (MEAT + WHEY) | Experimental | Dietary Supplement: PROTEINPost workout (training days) or breakfast (non training days) 20g of meat protein (10g meat + 10g whey) mixed with 200ml of orange juice and water |
| CARBOHYDRATE (CHO) | Placebo comparator | Dietary Supplement: CARBOHYDRATEPost workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml orange juice and water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years to 45
- Vo2max >50ml/kg/min
- Regularly trained athletes,
- Minimum 3 years 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 |
|---|---|---|
| PROTEINAlso: 100% BEEFImmediately (<10 min) after completing each training session (resistance training) participants will consume a beverage containing 20g of meat protein (10g) plus whey (10g) mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast. | Dietary supplement | PROTEIN (MEAT + WHEY) |
| CARBOHYDRATEAlso: MaltodextrinImmediately (<10 min) after completing each training session (resistance training), participants will consume a beverage containing about 20g of maltodextrin mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast. | Dietary supplement | CARBOHYDRATE (CHO) |
Primary outcome
% Fat Mass (Body composition)
Time frame: 10 weeks
Estimated with Densitometry (DEXA)
Visceral Adipose Tissue Mass (g) (Body composition)
Time frame: 10 weeks
Estimated with DEXA
Total Fat Free mass (g) (Body composition)
Time frame: 10 weeks
Estimated with DEXA
Bone mineral density (g/cm3) (Body composition)
Time frame: 10 weeks
Estimated with DEXA
22 secondary outcomes
Blood Glucose (mg/dl)
Time frame: 10 weeks
Creatine Kinase (Ul/l) -Blood markers-
Time frame: 10 weeks
Creatinine (mg/dl) - Blood markers -
Time frame: 10 weeks
Myoglobin (ng/ml) - Blood markers -
Time frame: 10 weeks
Total cholesterol (mg/dl) -Blood markers-
Time frame: 10 weeks
HDL cholesterol (mg/dl) -Blood markers-
Time frame: 10 weeks
LDL cholesterol (mg/dl) -Blood markers-
Time frame: 10 weeks
Aspartate amino transferasa (Ul/l) -Blood markers-
Time frame: 10 weeks
Triglycerides (mg/dl) -Blood markers-
Time frame: 10 weeks
Hemoglobin (g/dl) -Blood markers-
Time frame: 10 weeks
Erythrocyte (M/µL) -Blood markers-
Time frame: 10 weeks
Haematocrit (%) -Blood markers-
Time frame: 10 weeks
Mean corpuscular volume (cubic millimeter)-Blood markers-
Time frame: 10 weeks
Serum Transferrin (mg/dl) -Blood markers-
Time frame: 10 weeks
Transferrin saturation (%) -Blood markers-
Time frame: 10 weeks
Neutrophils (%) -Blood markers-
Time frame: 10 weeks
Lymphocyte (%) -Blood markers-
Time frame: 10 weeks
Monocytes (%) -Blood markers-
Time frame: 10 weeks
Ferritin, serum (ng/ml) -Blood markers-
Time frame: 10 weeks
Progressive maximal oxygen consumption test (Cardiorespiratory test)
Time frame: 10 weeks
Time to exhaustion at maximal aerobic (min)
Time frame: 10 weeks
Gut microbiota determination by 16S rRNA Sequencing
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Derived from this study: PubMed 36918416Moreno-Perez D, Lopez-Samanes A, Larrosa M, Larumbe-Zabala E, Centeno A, Roberts J, Naclerio F. Effects of protein-carbohydrate vs. carbohydrate alone supplementation on immune inflammation markers in endurance athletes: a randomized controlled trial. Eur J Appl Physiol. 2023 Jul;123(7):1495-1505. doi: 10.1007/s00421-023-05168-6. Epub 2023 Mar 14.
- 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.
DIEGO MORENO, PhD principal investigator
Universidad Europea de Madrid
FERNANDO NACLERIO, PhD principal investigator
University of Greenwich
Questions about this trial
What is this clinical trial studying?
A study testing PROTEIN and CARBOHYDRATE in people with Dietary Modification, run by Universidad Europea de Madrid.
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 5 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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. 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. 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?
% Fat Mass (Body composition) (time frame: 10 weeks). The study lists 4 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 NCT02954367, 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 3 Nov 2016.