- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675348
Beef Protein Supplementation in Endurance Athletes (Beef)
Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure, Immunological and Haematological Markers in Endurance Athletes
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kent
-
Chatham, Kent, United Kingdom, ME4 4TB
- Department of Life and Sports Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary Supplement: Beef Protein
All the groups will perform a similar endurance training involved 4 to 6 workout 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. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of beef protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
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
Other Names:
|
Experimental: Dietary Supplement: Whey Protein
All the groups will perform a similar endurance training involved 4 to 6 workout 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. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of whey protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
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
Other Names:
|
Active Comparator: Dietary Supplement: CHO
All the groups will perform a similar endurance training involved 4 to 6 workout 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. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of maltodextrin powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Markers
Time Frame: 10 weeks
|
haemoglobin
|
10 weeks
|
Blood Markers
Time Frame: 10 weeks
|
haematocrit
|
10 weeks
|
Body composition
Time Frame: 10 weeks
|
Fat-Free mass
|
10 weeks
|
Body composition
Time Frame: 10 Weeks
|
Fat mass
|
10 Weeks
|
Muscular thickness
Time Frame: 10 weeks
|
vastus medialis thickness
|
10 weeks
|
Endurance Performance
Time Frame: 10 weeks
|
Vo2max
|
10 weeks
|
Endurance Performance
Time Frame: 10 Weeks
|
Ventilatory threshold 2
|
10 Weeks
|
Blood Markers
Time Frame: 10 weeks
|
red blood cell
|
10 weeks
|
Blood Markers
Time Frame: 10 weeks
|
transferrin
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunology markers
Time Frame: 10 weeks
|
neutrophils
|
10 weeks
|
Immunology markers
Time Frame: 10 weeks
|
lymphocyte
|
10 weeks
|
Immunology markers
Time Frame: 10 weeks
|
monocytes
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fernando Naclerio, Ph D, University of Greenwich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- fES-uREC-15-1 3 02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Modification
-
University of ReadingUnknownDietary Habits | Dietary ModificationUnited Kingdom
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
Brown UniversityNational Cancer Institute (NCI); University of ConnecticutCompletedDietary Habits | Dietary Modification
-
University of ParmaCompletedDietary ModificationItaly
-
University of ParmaCompleted
-
University of ParmaCompletedDietary ModificationItaly
-
University of British ColumbiaCompleted
-
McMaster UniversityCompleted
-
University of ParmaCompletedDietary ModificationItaly
-
Universidad Europea de MadridUniversity of GreenwichUnknownDietary Modification
Clinical Trials on Dietary Supplement: Beef Protein
-
Texas Tech UniversityEHP LabsCompletedBody Weight Changes | Body Composition Changes | Anthropometric Changes | Metabolism Changes | Hemodynamic ChangesUnited States
-
University of Missouri-ColumbiaNational Cattlemen's Beef AssociationCompletedObesity | Poor Glycemic Control | Dietary Interventions
-
Lithuanian University of Health SciencesNot yet recruitingFrail Elderly Syndrome | Malnutrition; Protein
-
Arkansas Children's Hospital Research InstituteRecruiting
-
University of KansasDairy Management Inc.Completed
-
University of Sao Paulo General HospitalRecruitingAging | Sarcopenic ObesityBrazil
-
Wageningen University and ResearchNexira; Roquette Freres; Bioiberica; Ingredion Incorporated; Winclove Probiotics... and other collaboratorsCompletedIrritable Bowel SyndromeNetherlands
-
BeachbodyKGK Science Inc.; Glycemic Index Laboratories, Inc; MB Clinical Research and...CompletedOverweightUnited States, Canada
-
McMaster UniversityCompletedSkeletal Muscle HypertrophyCanada
-
Helsinki University Central HospitalCompleted