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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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 groups in NCT03281434
Study groupRoleWhat they receive
Collagen peptideActive comparatorSupplement will be delivered twice daily (30g per supplement) of hydrolyzed collagen peptides
Receives: Dietary Supplement: Collagen peptide
Whey proteinExperimentalSupplement 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.

  1. Acute myofibrillar muscle protein synthesis

    Assessed with stable isotope tracer infusion ([L-ring] 13C6 phenylalanine)

    Measured: 8 hours

  2. Medium length myofibrillar muscle protein synthesis

    Assessed with deuterated water

    Measured: 7 days

Secondary outcomes (1)
  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.

  1. First posted13 Sep 2017
  2. Study start1 Jan 2018
  3. Primary completion30 Aug 2018
  4. Study completion1 Aug 2019

Resources

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)
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

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.

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