NCT01062711

Brief Summary

When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

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

Study Start

First participant enrolled

July 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2.4 years

First QC Date

February 3, 2010

Last Update Submit

July 19, 2011

Conditions

Keywords

sarcopeniamuscleproteinmuscle protein synthesismuscle protein breakdownwheysoycaseindose responseresistance exerciseunilateralknee extensionwhole body protein

Outcome Measures

Primary Outcomes (2)

  • Muscle protein synthesis

    Acute within the day

  • whole body amino acid oxidation

    acute within the day

Secondary Outcomes (3)

  • muscle protein breakdown

    Acute within the day

  • serum insulin

    acute within the day

  • plasma amino acid concentrations

    acute within the day

Study Arms (7)

Control group 0 g protein

OTHER

Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

10g whey

EXPERIMENTAL

10g whey protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

20g whey

EXPERIMENTAL

20g whey protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

30g whey

EXPERIMENTAL

30g whey protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

40g whey

EXPERIMENTAL

40g whey protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

20g soy

EXPERIMENTAL

20g soy protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

40g soy

EXPERIMENTAL

40g soy protein given following unilateral knee extension exercise

Dietary Supplement: Whey or soy protein

Interventions

Whey or soy proteinDIETARY_SUPPLEMENT

Whey and casein are isolated milk proteins

10g whey20g soy20g whey30g whey40g soy40g wheyControl group 0 g protein

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Aged 60 to 80 years old
  • Non-smoker
  • Generally healthy and can tolerate the resistance exercise and protein drink

You may not qualify if:

  • Allergies to whey, casein or soy
  • Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
  • Failed clearance for exercise participation by their medical doctor
  • Failed an exercise stress test
  • Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
  • Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
  • Taking medications for lung and kidney conditions but excluding medication for asthma that is under control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

WheySoybean Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsSoy FoodsVegetable ProductsVegetables

Study Officials

  • Stuart Phillips, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations