- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01776359
Effects of High Protein Intake With Intense Exercise and Energy Deficit (RIPPED)
June 6, 2015 updated by: Stuart M. Phillips, McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 18-30 males
- Healthy
Exclusion Criteria:
- more than 15% body fat
- 35-50ml/kg/min VO2
- BMI grater than 27
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High Protein
|
2.4g/kg of protein
|
|
Placebo Comparator: Low Protein
|
1.2g/kg of protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition
Time Frame: 4 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological state
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1159/000012817.
- Butterfield GE, Calloway DH. Physical activity improves protein utilization in young men. Br J Nutr. 1984 Mar;51(2):171-84. doi: 10.1079/bjn19840021.
- Longland TM, Oikawa SY, Mitchell CJ, Devries MC, Phillips SM. Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial. Am J Clin Nutr. 2016 Mar;103(3):738-46. doi: 10.3945/ajcn.115.119339. Epub 2016 Jan 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 14, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 28, 2013
Study Record Updates
Last Update Posted (Estimate)
June 9, 2015
Last Update Submitted That Met QC Criteria
June 6, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 12-670
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.
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