AgingNCT03281434
The Effects of Whey vs. Collagen on MPS
A study testing Collagen peptide and Whey protein isolate in people with Aging, run by McMaster University at 2 sites in Canada.
Trial summary
With aging there is a natural loss of muscle mass and strength called sarcopenia, which increases the risk of falls and metabolic disease (i.e. Type II diabetes) and decreases the ability to perform activities of daily living. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Collagen peptide and Whey protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Ambulatory, and able to perform exercise
- Active (~3500-10,000 steps per day)
Who cannot join
- Smoker
- Diabetic
- Chronic conditions
- Consumption of medications known to affect muscle protein synthesis
- Statin myalgia
- Allergy to milk protein
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
Ivor Wynne Center
Hamilton, Ontario, L8S4K1
About this study
Official title: The Effects of Whey Versus Collagen Protein Intake on Acute and Longer-term Skeletal Muscle Protein Synthesis in Older Adults
With aging there is a natural loss of muscle mass and strength called sarcopenia, which increases the risk of falls and metabolic disease (i.e. Type II diabetes) and decreases the ability to perform activities of daily living. Eating protein and doing resistance exercise both increase the body's ability to make muscle protein, which is important to offset losses in muscle mass; however, older adults have a lower appetite and do not consume enough calories or protein to crease muscle and as such investigations in this population are needed. The amino acid (the building blocks of proteins) leucine is known to increase the ability of protein to make muscle. In this study we will investigate the ability of beverages with different types of protein and leucine to create muscle in older men and women whoa re particularly vulnerable to muscle losses and do not eat enough protein and are understudied in this area.
Read the detailed description
The age-related decline in skeletal muscle mass and strength, termed sarcopenia, is associated with a host of metabolic disease states including, but not limited to, cancer, stroke, microvascular disease, type 2 diabetes, Parkinson's and Alzheimer's. Moreover, declines in skeletal muscle mass also are accompanied by an even more precipitous reduction in skeletal muscle strength, known as dynapenia, which is a predisposition for disability and falls. Sarcopenia begins in the 5th decade of life and proceeds, at least based on population-derived estimates, at a ~0.8% loss annually, with strength losses being greater and more variable at 2-5% year past the age of 50. Strategies to offset the loss of muscle mass with aging are imperative for the maintenance of quality of life and ability to perform activities of daily living in an older population.
Losses of skeletal muscle mass are underpinned by an imbalance between rates of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). In healthy humans it is known that the change in the rate of MPS in response to contractile activity and protein feeding is the primary locus of control for human muscle mass. With aging, basal levels of MPS do not change in comparison to younger adults, however elevation in MPS response following an anabolic stimulus such as resistance exercise or protein ingestion are blunted when participants are exposed to the same stimulus, termed anabolic resistance. For example, older adults require 3-6 times the amount of resistance exercise volume and a 0.4 g/kg compared to 0.24 g/kg dose of high quality protein into order to stimulate basal rates of muscle protein synthesis.
Protein quality and dose are also critical when targeting maximal increases in MPS. The importance of amino acid digestibility is crucial as undigested dietary proteins may be unabsorbed and excreted rather than being absorbed in the small intestine or contributions to lean mass. The Food and Agriculture Organization has endorsed the digestible indispensable amino acid score (DIAAS) to assess protein quality as it is able to distinguish between proteins that were previously classed at an equivalent value. Using the DIAAS, proteins with the highest digestibility and quality scores are the two main milk proteins casein and whey, which have scores of 1.18 and 1.09, respectively whereas hydrolyzed collagen peptides (derived from bones and cartilaginous tissues) has a score of 0 as it lacks the amino acid tryptophan. Importantly, casein and whey have higher leucine contents than collagen peptides, including more of other essential amino acids. This is particularly important as data from our own laboratory has demonstrated that increasing the leucine concentration of a low protein mixed macronutrient beverage rescues rates of postprandial MPS to those seen with higher protein content. Moreover, leucine is a key trigger of the mechanistic target of rapamycin complex 1 (mTORC1), a 280-kDa serine/threonine kinase known to activate key translation initiation factors involved in MPS. Thus, protein doses of lower quality such as hydrolyzed collagen would in theory require a greater dose in order to elicit a similar response to whey or casein.
The use of hydrolyzed collagen as a supplement to enhance skeletal muscle anabolism has been scarcely examined previously literature with most studies in humans involving the use of collagen peptide supplementation to enhance collagen-containing tissues such as hair, skin and cartilaginous joints. Of the current literature, supplementation with collagen peptides in combination with resistance exercise was found to have remarkable effects on the accrual of lean mass in older men with a concomitant remarkable decrease in fat mass within a 12-week training period. It was also found to have remarkable effects on nitrogen balance in older women in comparison to whey protein despite a leucine content in collagen that is 1/16th of that found in whey protein isolate. If the anabolic potential of hydrolyzed collagen is able to match that of whey protein, it may provide an important, cost effective, and feasible method by which older adults are able to achieve suggested protein recommendations.
Protein ingestion following resistance exercise provides a potent and additive stimulus over either anabolic influence alone. A resistance exercise bout has been shown to sensitize the muscle to the effects of protein. Our lab has previously shown that older adults achieve the greatest increase in MPS following a resistance exercise bout when consuming 40 g of whey protein and that this effect was greater than consuming 40 g of protein without exercise. It will be crucial to our understanding of the protein needs of older adults to determine whether consumption of whey protein and collagen peptides are indeed equivalent and can be used to augment the muscle protein synthetic response following resistance exercise in older adults.
Many studies that assess acute changes in rates of MPS in response to protein intake do so by infusing a labeled amino acid tracer and calculating the incorporation of that tracer into skeletal muscle over a period of hours. While this approach provides important information, especially when coupled with quantitative measures of changes in muscle mass such a MRI, the assessment of tracer-infusion measured MPS is limited to ~5-6 h. Thus, recent developments of analytical techniques have enabled the use of a deuterated water methodology that enables assessment of MPS with much longer periods of incorporation i.e., days-to-weeks. Indeed, this method has been recently validated and its use is now becoming the interest of many researchers. However, only a few laboratories have demonstrated the ability to competently perform this measurement. In fact, we have recently conducted two studies using this methodology, and the MPS values that we obtained are entirely consistent with published reports. We propose that the use of the deuterated water methodology in combination with the use of stable isotope tracers, will provide us with measurements of MPS in both a controlled-acute and a free-living situation and would be a substantial advance in determining mechanisms underpinning protein ingestion and aging.
- Conditions
- Aging
- Being tested
- Collagen peptide, Whey protein isolate
- Keywords
- Skeletal muscle, Protein synthesis, Protein ingestion, Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen peptideDietary supplement
Low leucine content protein supplement to be consumed twice daily
Whey protein isolateDietary supplement
High quality protein (DIAAS score), high leucine supplement, to be consumed twice daily
| Study group | Role | What they receive |
|---|---|---|
| Collagen peptide | Active comparator | Supplement will be delivered twice daily (30g per supplement) of hydrolyzed collagen peptides Receives: Dietary Supplement: Collagen peptide |
| Whey protein | Experimental | Supplement will be delivered twice daily (30g per supplement) of whey protein isolate Receives: Dietary Supplement: Whey protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute myofibrillar muscle protein synthesis
Assessed with stable isotope tracer infusion ([L-ring] 13C6 phenylalanine)
Measured: 8 hours
Medium length myofibrillar muscle protein synthesis
Assessed with deuterated water
Measured: 7 days
Secondary outcomes (1)
Fasted glucose, insulin and oxidative stress (IL6, TNF-a, CRP)
Measured with a fasted blood sample
Measured: Assessed every 2 days throughout the 7 day monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2018
- Primary completion30 Aug 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group design (with repeated measurements within each group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart M Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281434
- Sponsor's protocol ID
- HIREB 3916
- Status last verified
- Feb 2020
- First submitted
- 11 Sep 2017
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oikawa SY, Kamal MJ, Webb EK, McGlory C, Baker SK, Phillips SM. Whey protein but not collagen peptides stimulate acute and longer-term muscle protein synthesis with and without resistance exercise in healthy older women: a randomized controlled trial. Am J Clin Nutr. 2020 Mar 1;111(3):708-718. doi: 10.1093/ajcn/nqz332.
PubMed 31919527
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whey Versus Collagen Protein Intake on Acute and Longer-term Skeletal Muscle Protein Synthesis in Older Adults
- ClinicalTrials.gov ID
- NCT03281434
- Acronym / sponsor ID
- HIREB 3916
- Conditions
- Aging
- Keywords
- Skeletal muscle, Protein synthesis, Protein ingestion, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With aging there is a natural loss of muscle mass and strength called sarcopenia, which increases the risk of falls and metabolic disease (i.e. Type II diabetes) and decreases the ability to perform activities of daily living. Eating protein and doing resistance exercise both increase the body's ability to make muscle protein, which is important to offset losses in muscle mass; however, older adults have a lower appetite and do not consume enough calories or protein to crease muscle and as such investigations in this population are needed. The amino acid (the building blocks of proteins) leucine is known to increase the ability of protein to make muscle. In this study we will investigate the ability of beverages with different types of protein and leucine to create muscle in older men and women whoa re particularly vulnerable to muscle losses and do not eat enough protein and are understudied in this area.
Detailed description
The age-related decline in skeletal muscle mass and strength, termed sarcopenia, is associated with a host of metabolic disease states including, but not limited to, cancer, stroke, microvascular disease, type 2 diabetes, Parkinson's and Alzheimer's. Moreover, declines in skeletal muscle mass also are accompanied by an even more precipitous reduction in skeletal muscle strength, known as dynapenia, which is a predisposition for disability and falls. Sarcopenia begins in the 5th decade of life and proceeds, at least based on population-derived estimates, at a ~0.8% loss annually, with strength losses being greater and more variable at 2-5% year past the age of 50. Strategies to offset the loss of muscle mass with aging are imperative for the maintenance of quality of life and ability to perform activities of daily living in an older population.
Losses of skeletal muscle mass are underpinned by an imbalance between rates of muscle protein synthesis (MPS) and muscle protein breakdown (MPB). In healthy humans it is known that the change in the rate of MPS in response to contractile activity and protein feeding is the primary locus of control for human muscle mass. With aging, basal levels of MPS do not change in comparison to younger adults, however elevation in MPS response following an anabolic stimulus such as resistance exercise or protein ingestion are blunted when participants are exposed to the same stimulus, termed anabolic resistance. For example, older adults require 3-6 times the amount of resistance exercise volume and a 0.4 g/kg compared to 0.24 g/kg dose of high quality protein into order to stimulate basal rates of muscle protein synthesis.
Protein quality and dose are also critical when targeting maximal increases in MPS. The importance of amino acid digestibility is crucial as undigested dietary proteins may be unabsorbed and excreted rather than being absorbed in the small intestine or contributions to lean mass. The Food and Agriculture Organization has endorsed the digestible indispensable amino acid score (DIAAS) to assess protein quality as it is able to distinguish between proteins that were previously classed at an equivalent value. Using the DIAAS, proteins with the highest digestibility and quality scores are the two main milk proteins casein and whey, which have scores of 1.18 and 1.09, respectively whereas hydrolyzed collagen peptides (derived from bones and cartilaginous tissues) has a score of 0 as it lacks the amino acid tryptophan. Importantly, casein and whey have higher leucine contents than collagen peptides, including more of other essential amino acids. This is particularly important as data from our own laboratory has demonstrated that increasing the leucine concentration of a low protein mixed macronutrient beverage rescues rates of postprandial MPS to those seen with higher protein content. Moreover, leucine is a key trigger of the mechanistic target of rapamycin complex 1 (mTORC1), a 280-kDa serine/threonine kinase known to activate key translation initiation factors involved in MPS. Thus, protein doses of lower quality such as hydrolyzed collagen would in theory require a greater dose in order to elicit a similar response to whey or casein.
The use of hydrolyzed collagen as a supplement to enhance skeletal muscle anabolism has been scarcely examined previously literature with most studies in humans involving the use of collagen peptide supplementation to enhance collagen-containing tissues such as hair, skin and cartilaginous joints. Of the current literature, supplementation with collagen peptides in combination with resistance exercise was found to have remarkable effects on the accrual of lean mass in older men with a concomitant remarkable decrease in fat mass within a 12-week training period. It was also found to have remarkable effects on nitrogen balance in older women in comparison to whey protein despite a leucine content in collagen that is 1/16th of that found in whey protein isolate. If the anabolic potential of hydrolyzed collagen is able to match that of whey protein, it may provide an important, cost effective, and feasible method by which older adults are able to achieve suggested protein recommendations.
Protein ingestion following resistance exercise provides a potent and additive stimulus over either anabolic influence alone. A resistance exercise bout has been shown to sensitize the muscle to the effects of protein. Our lab has previously shown that older adults achieve the greatest increase in MPS following a resistance exercise bout when consuming 40 g of whey protein and that this effect was greater than consuming 40 g of protein without exercise. It will be crucial to our understanding of the protein needs of older adults to determine whether consumption of whey protein and collagen peptides are indeed equivalent and can be used to augment the muscle protein synthetic response following resistance exercise in older adults.
Many studies that assess acute changes in rates of MPS in response to protein intake do so by infusing a labeled amino acid tracer and calculating the incorporation of that tracer into skeletal muscle over a period of hours. While this approach provides important information, especially when coupled with quantitative measures of changes in muscle mass such a MRI, the assessment of tracer-infusion measured MPS is limited to ~5-6 h. Thus, recent developments of analytical techniques have enabled the use of a deuterated water methodology that enables assessment of MPS with much longer periods of incorporation i.e., days-to-weeks. Indeed, this method has been recently validated and its use is now becoming the interest of many researchers. However, only a few laboratories have demonstrated the ability to competently perform this measurement. In fact, we have recently conducted two studies using this methodology, and the MPS values that we obtained are entirely consistent with published reports. We propose that the use of the deuterated water methodology in combination with the use of stable isotope tracers, will provide us with measurements of MPS in both a controlled-acute and a free-living situation and would be a substantial advance in determining mechanisms underpinning protein ingestion and aging.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group design (with repeated measurements within each group)
| Arm | Type | Receives |
|---|---|---|
| Collagen peptide | Active comparator | Dietary Supplement: Collagen peptideSupplement will be delivered twice daily (30g per supplement) of hydrolyzed collagen peptides |
| Whey protein | Experimental | Dietary Supplement: Whey protein isolateSupplement will be delivered twice daily (30g per supplement) of whey protein isolate |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Ambulatory, and able to perform exercise
- Active (~3500-10,000 steps per day)
Key exclusion criteria (6 listed)
- Smoker
- Diabetic
- Chronic conditions
- Consumption of medications known to affect muscle protein synthesis
- Statin myalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen peptideLow leucine content protein supplement to be consumed twice daily | Dietary supplement | Collagen peptide |
| Whey protein isolateHigh quality protein (DIAAS score), high leucine supplement, to be consumed twice daily | Dietary supplement | Whey protein |
Primary outcome
Acute myofibrillar muscle protein synthesis
Time frame: 8 hours
Assessed with stable isotope tracer infusion ([L-ring] 13C6 phenylalanine)
Medium length myofibrillar muscle protein synthesis
Time frame: 7 days
Assessed with deuterated water
1 secondary outcome
Fasted glucose, insulin and oxidative stress (IL6, TNF-a, CRP)
Time frame: Assessed every 2 days throughout the 7 day monitoring period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Results publication: PubMed 31919527Oikawa SY, Kamal MJ, Webb EK, McGlory C, Baker SK, Phillips SM. Whey protein but not collagen peptides stimulate acute and longer-term muscle protein synthesis with and without resistance exercise in healthy older women: a randomized controlled trial. Am J Clin Nutr. 2020 Mar 1;111(3):708-718. doi: 10.1093/ajcn/nqz332.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart M Phillips, Ph.D. principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen peptide and Whey protein isolate in people with Aging, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute myofibrillar muscle protein synthesis (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.