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临床试验/NCT02954367
NCT02954367Unknown不适用

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

Universidad Europea de Madrid0 个研究点目标入组 44 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
44
主要终点
Visceral Adipose Tissue Mass (g) (Body composition)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Visceral Adipose Tissue Mass (g) (Body composition)

时间窗: 10 weeks

Estimated with DEXA

Total Fat Free mass (g) (Body composition)

时间窗: 10 weeks

Estimated with DEXA

% Fat Mass (Body composition)

时间窗: 10 weeks

Estimated with Densitometry (DEXA)

Bone mineral density (g/cm3) (Body composition)

时间窗: 10 weeks

Estimated with DEXA

次要结局

  • Aspartate amino transferasa (Ul/l) -Blood markers-(10 weeks)
  • Haematocrit (%) -Blood markers-(10 weeks)
  • LDL cholesterol (mg/dl) -Blood markers-(10 weeks)
  • Triglycerides (mg/dl) -Blood markers-(10 weeks)
  • Hemoglobin (g/dl) -Blood markers-(10 weeks)
  • Transferrin saturation (%) -Blood markers-(10 weeks)
  • Monocytes (%) -Blood markers-(10 weeks)
  • Time to exhaustion at maximal aerobic (min)(10 weeks)
  • Creatine Kinase (Ul/l) -Blood markers-(10 weeks)
  • Mean corpuscular volume (cubic millimeter)-Blood markers-(10 weeks)
  • Progressive maximal oxygen consumption test (Cardiorespiratory test)(10 weeks)
  • Total cholesterol (mg/dl) -Blood markers-(10 weeks)
  • Erythrocyte (M/µL) -Blood markers-(10 weeks)
  • Serum Transferrin (mg/dl) -Blood markers-(10 weeks)
  • Lymphocyte (%) -Blood markers-(10 weeks)
  • Ferritin, serum (ng/ml) -Blood markers-(10 weeks)
  • Blood Glucose (mg/dl)(10 weeks)
  • HDL cholesterol (mg/dl) -Blood markers-(10 weeks)
  • Neutrophils (%) -Blood markers-(10 weeks)
  • Gut microbiota determination by 16S rRNA Sequencing(10 weeks)
  • Creatinine (mg/dl) - Blood markers -(10 weeks)
  • Myoglobin (ng/ml) - Blood markers -(10 weeks)

研究者

发起方
Universidad Europea de Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

DIEGO MORENO PÉREZ

PhD

Universidad Europea de Madrid

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