Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02675348
Other study ID # fES-uREC-15-1 3 02
Secondary ID
Status Completed
Phase N/A
First received February 2, 2016
Last updated May 7, 2017
Start date January 2016
Est. completion date February 2017

Study information

Verified date May 2017
Source University of Greenwich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates beef protein extract compared to the ingestion of others commercially available protein sources such as whey and non protein only carbohydrate contrast nutrients.


Description:

This investigation involves a 10 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates beef protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, body composition and blood markers after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (Beef); 2) Whey (Whey) and 3) non-protein iso-energetic placebo (CHO).

Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: Beef; Whey and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the three specific supplementation treatments (Beef, Whey or CHO). Measurements of blood, body composition, muscle structure and endurance performance will be determined before and after the training intervention.

Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance (Vo2max). 1) The Beef protein group (Beef n=12) that will take 20g of hydrolysates beef protein powder and 250 ml of water 2) The whey group (n=12) will take 20 g of whey intact isolate powder mixed with 250 ml of water 3) the contrast group (CHO n=12) that will take an iso-energetic non-protein, only carbohydrate (20 f of maltodextrin plus 250 ml of water) contrast.

Participants: Thirty six participants, recruited from Kent, Medway University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.

Intervention Familiarization period: Participants will undertake 1 sessions of familiarisation with the testing procedure. A qualified conditioning coach will control and assists participants in order to guarantee a correct understanding of the assessment procedure (Body composition, vo2max test, muscle thickness, etc). All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (6-20) Borg scale and the heart rate monitor to control the load and training intensity during test and training.

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] (Esteve-Lanao et al., 2007). Participants will train 4 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.

Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast.

Supplements and placebo will be provided in powder form and should be mixed with 250 ml of plain water at the moment of consumption. Supplements and placebo will looks and tastes identical.

Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 70 doses for a total of 10 weeks of study intervention.

Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- regularly trained endurance athletes,

- aged 30 to 60 years old,

- minimum 2 years of experience,

- 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary Supplement: Beef Protein
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
Dietary Supplement: whey Protein
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
Dietary Supplement: CHO
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

Locations

Country Name City State
United Kingdom Department of Life and Sports Science Chatham Kent

Sponsors (1)

Lead Sponsor Collaborator
University of Greenwich

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body composition Fat-Free mass 10 weeks
Primary Body composition Fat mass 10 Weeks
Primary Muscular thickness vastus medialis thickness 10 weeks
Primary Endurance Performance Vo2max 10 weeks
Primary Endurance Performance Ventilatory threshold 2 10 Weeks
Primary Blood Markers haemoglobin 10 weeks
Primary Blood Markers red blood cell 10 weeks
Primary Blood Markers haematocrit 10 weeks
Primary Blood Markers transferrin 10 weeks
Secondary Immunology markers neutrophils 10 weeks
Secondary Immunology markers lymphocyte 10 weeks
Secondary Immunology markers monocytes 10 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Completed NCT03024983 - Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism N/A
Completed NCT02480504 - Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity N/A
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Completed NCT02416284 - Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females N/A
Completed NCT01559896 - Egg Protein Hydrolysate and Vascular Function N/A
Terminated NCT01329172 - Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients N/A
Completed NCT03698929 - Effect of Dietary Cholesterol on Plasma Lipids N/A
Completed NCT03942822 - Chia Supplementation and Non Alcoholic Fatty Liver Disease N/A
Completed NCT03319836 - Meeting Protein Targets in Critically Ill Patients
Completed NCT02940197 - Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers N/A
Completed NCT02811276 - The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism N/A
Completed NCT02582554 - Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers N/A
Completed NCT02574052 - Medical College Students' Responds to Menu Labeling Phase 3
Completed NCT02274220 - Feeding Study - Effects Post-cardiac Surgery N/A
Completed NCT02898844 - Randomized Controlled Experiment of Dieting in Pairs N/A