Meat and Whey Protein Supplementation in Endurance Athletes

Dietary Modification Clinical Trial

Official title:

Effects of Meat Protein Administration on Body Composition, Strength, Immunological, Microbiota and Haematological Markers in Endurance Athletes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02954367
• Other study ID #: BEEF-UEM-01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: November 1, 2016
• Start date: April 2016

Study information

• Verified date: November 2016
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEIC Puerta hierro
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Modification

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	University of Greenwich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Fat Mass (Body composition)	Estimated with Densitometry (DEXA)	10 weeks	No
Primary	Visceral Adipose Tissue Mass (g) (Body composition)	Estimated with DEXA	10 weeks	No
Primary	Total Fat Free mass (g) (Body composition)	Estimated with DEXA	10 weeks	No
Primary	Bone mineral density (g/cm3) (Body composition)	Estimated with DEXA	10 weeks	No
Secondary	Blood Glucose (mg/dl)		10 weeks	No
Secondary	Creatine Kinase (Ul/l) -Blood markers-		10 weeks	No
Secondary	Creatinine (mg/dl) - Blood markers -		10 weeks	No
Secondary	Myoglobin (ng/ml) - Blood markers -		10 weeks	No
Secondary	Total cholesterol (mg/dl) -Blood markers-		10 weeks	No
Secondary	HDL cholesterol (mg/dl) -Blood markers-		10 weeks	No
Secondary	LDL cholesterol (mg/dl) -Blood markers-		10 weeks	No
Secondary	Aspartate amino transferasa (Ul/l) -Blood markers-		10 weeks	No
Secondary	Triglycerides (mg/dl) -Blood markers-		10 weeks	No
Secondary	Hemoglobin (g/dl) -Blood markers-		10 weeks	No
Secondary	Erythrocyte (M/µL) -Blood markers-		10 weeks	No
Secondary	Haematocrit (%) -Blood markers-		10 weeks	No
Secondary	Mean corpuscular volume (cubic millimeter)-Blood markers-		10 weeks	No
Secondary	Serum Transferrin (mg/dl) -Blood markers-		10 weeks	No
Secondary	Transferrin saturation (%) -Blood markers-		10 weeks	No
Secondary	Neutrophils (%) -Blood markers-		10 weeks	No
Secondary	Lymphocyte (%) -Blood markers-		10 weeks	No
Secondary	Monocytes (%) -Blood markers-		10 weeks	No
Secondary	Ferritin, serum (ng/ml) -Blood markers-		10 weeks	No
Secondary	Progressive maximal oxygen consumption test (Cardiorespiratory test)	- Maximum oxygen uptake (ml/kg/min)	10 weeks	No
Secondary	Time to exhaustion at maximal aerobic (min)		10 weeks	No
Secondary	Gut microbiota determination by 16S rRNA Sequencing		10 weeks	No