- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062711
Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men (NDC)
July 19, 2011 updated by: McMaster University
Responses of Muscle and Whole-body Protein Turnover to Ingestion of Differing Doses of Whey and Soy Protein With and Without Resistance Exercise in Elderly Men
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
81
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 4K1
- 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
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Aged 60 to 80 years old
- Non-smoker
- Generally healthy and can tolerate the resistance exercise and protein drink
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group 0 g protein
Control group in which a placebo drink containing no protein is given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 10g whey
10g whey protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 20g whey
20g whey protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 30g whey
30g whey protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 40g whey
40g whey protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 20g soy
20g soy protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
Experimental: 40g soy
40g soy protein given following unilateral knee extension exercise
|
Whey and casein are isolated milk proteins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle protein synthesis
Time Frame: Acute within the day
|
Acute within the day
|
whole body amino acid oxidation
Time Frame: acute within the day
|
acute within the day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle protein breakdown
Time Frame: Acute within the day
|
Acute within the day
|
serum insulin
Time Frame: acute within the day
|
acute within the day
|
plasma amino acid concentrations
Time Frame: acute within the day
|
acute within the day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart Phillips, Ph.D., McMaster University
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
July 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
February 3, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 4, 2010
Study Record Updates
Last Update Posted (Estimate)
July 20, 2011
Last Update Submitted That Met QC Criteria
July 19, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMI 1484
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 Sarcopenia
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on Whey or soy protein
-
Maastricht University Medical CenterEuropean Dairy Association (EDA), BrusselsCompletedChronic Obstructive Pulmonary DiseaseNetherlands
-
University of Sao PauloCompleted
-
Chulalongkorn UniversityCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson Disease | Parkinsonian Disorders | Basal Ganglia Diseases | Movement Disorders | Neurodegenerative DiseasesThailand
-
Peking Union Medical College HospitalNot yet recruitingLung Cancer | SarcopeniaChina
-
University of ThessalyCompletedAthletic Performance | Muscle Damage | Skeletal Muscle DamageGreece
-
United States Department of Agriculture (USDA)Completed
-
Auburn UniversityCompletedSkeletal Muscle
-
Martin-Luther-Universität Halle-WittenbergUniversity of Halle Medical Faculty; UFOP Union for the promotion of oil and...Completed
-
University of FloridaCompletedRenal Failure | Chronic Kidney Disease Requiring Chronic DialysisUnited States
-
University of KansasDairy Management Inc.Completed