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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01776359
Other study ID # REB 12-670
Secondary ID
Status Completed
Phase N/A
First received January 14, 2013
Last updated June 6, 2015
Start date February 2013
Est. completion date December 2014

Study information

Verified date June 2015
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Hamilton Health Sciences
Study type Interventional

Clinical Trial Summary

A four week intervention will take place with the participants. They will undergo 6 days a week of high intensity training. They will also be at a 40% energy deficiency. One group will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis that the participants with the higher protein will retain more lean mass.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- 18-30 males

- Healthy

Exclusion Criteria:

- more than 15% body fat

- 35-50ml/kg/min VO2

- BMI grater than 27

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High Protein
2.4g/kg of protein
Low Protein
1.2g/kg of protein

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Butterfield GE, Calloway DH. Physical activity improves protein utilization in young men. Br J Nutr. 1984 Mar;51(2):171-84. — View Citation

Demling RH, DeSanti L. Effect of a hypocaloric diet, increased protein intake and resistance training on lean mass gains and fat mass loss in overweight police officers. Ann Nutr Metab. 2000;44(1):21-9. — View Citation

Mettler S, Mitchell N, Tipton KD. Increased protein intake reduces lean body mass loss during weight loss in athletes. Med Sci Sports Exerc. 2010 Feb;42(2):326-37. doi: 10.1249/MSS.0b013e3181b2ef8e. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Composition To compare the effect of normal protein intake (1.2 g/kg per day) and increased protein intake (2.4 g/kg per day) on body composition over a 4 week period of energy restriction in young males (18-30), with intense exercise training. Body composition will be measured via DXA, Bod Pod, Bio-impedance, skin folds. 4 weeks No
Secondary Psychological state To compare the psychological state of the participants, before, during and after the intervention. To see if the mind will grow with the body as high intensity exercise is performed, or whether the mind will tire and scores will be reduced. Measurement tactics will in include POMS, and PANAS questionnaires for mood, and stroop, isometric hand grip, operation span test, and vigilance task. 4 weeks No
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