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Trial record 7 of 53 for:    whey protein | maltodextrin

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

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

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Supplement: PROTEIN Dietary Supplement: CARBOHYDRATE Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Meat Protein Administration on Body Composition, Strength, Immunological, Microbiota and Haematological Markers in Endurance Athletes
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017

Arm Intervention/treatment
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
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

Placebo Comparator: CARBOHYDRATE (CHO)
Post workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml orange juice and water
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




Primary Outcome Measures :
  1. % Fat Mass (Body composition) [ Time Frame: 10 weeks ]
    Estimated with Densitometry (DEXA)

  2. Visceral Adipose Tissue Mass (g) (Body composition) [ Time Frame: 10 weeks ]
    Estimated with DEXA

  3. Total Fat Free mass (g) (Body composition) [ Time Frame: 10 weeks ]
    Estimated with DEXA

  4. Bone mineral density (g/cm3) (Body composition) [ Time Frame: 10 weeks ]
    Estimated with DEXA


Secondary Outcome Measures :
  1. Blood Glucose (mg/dl) [ Time Frame: 10 weeks ]
  2. Creatine Kinase (Ul/l) -Blood markers- [ Time Frame: 10 weeks ]
  3. Creatinine (mg/dl) - Blood markers - [ Time Frame: 10 weeks ]
  4. Myoglobin (ng/ml) - Blood markers - [ Time Frame: 10 weeks ]
  5. Total cholesterol (mg/dl) -Blood markers- [ Time Frame: 10 weeks ]
  6. HDL cholesterol (mg/dl) -Blood markers- [ Time Frame: 10 weeks ]
  7. LDL cholesterol (mg/dl) -Blood markers- [ Time Frame: 10 weeks ]
  8. Aspartate amino transferasa (Ul/l) -Blood markers- [ Time Frame: 10 weeks ]
  9. Triglycerides (mg/dl) -Blood markers- [ Time Frame: 10 weeks ]
  10. Hemoglobin (g/dl) -Blood markers- [ Time Frame: 10 weeks ]
  11. Erythrocyte (M/µL) -Blood markers- [ Time Frame: 10 weeks ]
  12. Haematocrit (%) -Blood markers- [ Time Frame: 10 weeks ]
  13. Mean corpuscular volume (cubic millimeter)-Blood markers- [ Time Frame: 10 weeks ]
  14. Serum Transferrin (mg/dl) -Blood markers- [ Time Frame: 10 weeks ]
  15. Transferrin saturation (%) -Blood markers- [ Time Frame: 10 weeks ]
  16. Neutrophils (%) -Blood markers- [ Time Frame: 10 weeks ]
  17. Lymphocyte (%) -Blood markers- [ Time Frame: 10 weeks ]
  18. Monocytes (%) -Blood markers- [ Time Frame: 10 weeks ]
  19. Ferritin, serum (ng/ml) -Blood markers- [ Time Frame: 10 weeks ]
  20. Progressive maximal oxygen consumption test (Cardiorespiratory test) [ Time Frame: 10 weeks ]
    - Maximum oxygen uptake (ml/kg/min)

  21. Time to exhaustion at maximal aerobic (min) [ Time Frame: 10 weeks ]
  22. Gut microbiota determination by 16S rRNA Sequencing [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954367


Sponsors and Collaborators
Universidad Europea de Madrid
University of Greenwich
Investigators
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Principal Investigator: DIEGO MORENO, PhD Universidad Europea de Madrid
Principal Investigator: FERNANDO NACLERIO, PhD University of Greenwich

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Responsible Party: DIEGO MORENO PÉREZ, PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT02954367     History of Changes
Other Study ID Numbers: BEEF-UEM-01
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No