NCT01776359

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

January 14, 2013

Last Update Submit

June 6, 2015

Conditions

Keywords

MuscleProteinDietExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Psychological state

    4 weeks

Study Arms (2)

High Protein

ACTIVE COMPARATOR

High Protein

Dietary Supplement: High Protein

Low Protein

PLACEBO COMPARATOR

Low Protein

Dietary Supplement: Low Protein

Interventions

High ProteinDIETARY_SUPPLEMENT

2.4g/kg of protein

High Protein
Low ProteinDIETARY_SUPPLEMENT

1.2g/kg of protein

Low Protein

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males
  • Healthy

You may not qualify if:

  • more than 15% body fat
  • ml/kg/min VO2
  • BMI grater than 27

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 19927027BACKGROUND
  • 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.

    PMID: 10838463BACKGROUND
  • 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.

    PMID: 6704368BACKGROUND
  • 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.

MeSH Terms

Conditions

OverweightMotor Activity

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 28, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations