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Meat and Whey Protein Supplementation in Endurance Athletes

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ClinicalTrials.gov Identifier: NCT02954367
Recruitment Status : Unknown
Verified November 2016 by DIEGO MORENO PÉREZ, Universidad Europea de Madrid.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
University of Greenwich
Information provided by (Responsible Party):
DIEGO MORENO PÉREZ, Universidad Europea de Madrid

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE November 3, 2016
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • % 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • 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 ]
    - Maximum oxygen uptake (ml/kg/min)
  • Time to exhaustion at maximal aerobic (min) [ Time Frame: 10 weeks ]
  • Gut microbiota determination by 16S rRNA Sequencing [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Meat and Whey Protein Supplementation in Endurance Athletes
Official Title  ICMJE Effects of Meat Protein Administration on Body Composition, Strength, Immunological, Microbiota and Haematological Markers in Endurance Athletes
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dietary Modification
Intervention  ICMJE
  • Dietary Supplement: PROTEIN
    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.
    Other Name: 100% BEEF
  • Dietary Supplement: CARBOHYDRATE
    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.
    Other Name: Maltodextrin
Study Arms  ICMJE
  • Experimental: PROTEIN (MEAT + WHEY)
    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
    Intervention: Dietary Supplement: PROTEIN
  • Placebo Comparator: CARBOHYDRATE (CHO)
    Post workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml orange juice and water
    Intervention: Dietary Supplement: CARBOHYDRATE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
44
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years to 45
  • Vo2max >50ml/kg/min
  • Regularly trained athletes,
  • Minimum 3 years of experience in resistance training exercise,
  • Volunteers,

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02954367
Other Study ID Numbers  ICMJE BEEF-UEM-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DIEGO MORENO PÉREZ, Universidad Europea de Madrid
Study Sponsor  ICMJE Universidad Europea de Madrid
Collaborators  ICMJE University of Greenwich
Investigators  ICMJE
Principal Investigator: DIEGO MORENO, PhD Universidad Europea de Madrid
Principal Investigator: FERNANDO NACLERIO, PhD University of Greenwich
PRS Account Universidad Europea de Madrid
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP