AgingNCT05301179
Protein Quantity and Quality in Older Subjects
A study testing Protein quantity and quality in people with Aging, run by McMaster University at 1 site in Canada.
Trial summary
After the age of ~50, humans start to lose muscle mass at a rate of about 1-3% per year. However, the loss of muscle mass beyond a certain point can make it increasingly difficult to perform activities of daily living such as rising from a chair, going up and downstairs, carrying groceries, etc. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Protein quantity and quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2021to 30 Apr 2025
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be a male or female, between the ages of 65 - 80 years (inclusive)
- Be willing and able to provide informed consent
- Be in general good health, non-smoking
- Have a body mass index (BMI) between 20-35 kg/m2 (inclusive)
Who cannot join
- Use of tobacco or related products.
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
- Use assistive walking devices (e.g., cane or walker)
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives.
- Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders
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- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Hypersensitivity or known allergy to any of the components in the diets.
- Excessive alcohol consumption (>21 units/week)
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted).
- History of statin myalgia.
- Personal or family history of a clotting disorder or deep vein thrombosis;
- Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein, or branched-chain amino acids (BCAAs) within 45 days prior to screening.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: The Mechanistic Underpinning of Protein Quality and Quantity in Aging Skeletal Muscle: A High Sensitivity Dynamic Proteome Profiling Approach
After the age of ~50, humans start to lose muscle mass at a rate of about 1-3% per year. However, the loss of muscle mass beyond a certain point can make it increasingly difficult to perform activities of daily living such as rising from a chair, going up and downstairs, carrying groceries, etc. A reason why muscle mass is lost with age is that skeletal muscles become less sensitive to the growth-promoting effects of physical activity and protein ingestion. This loss of sensitivity can be overcome by consuming larger amounts of protein; however, many older adults have difficulties simply consuming greater amounts of protein from whole-food sources. Therefore, the research in this study aims to investigate how different amounts and types of protein, of either a 100%-plant-based or Lacto-vegetarian (plant-based plus dairy) protein sources, affect muscle growth. This information will be important when providing information to older adults about the amount and type of protein that should be consumed by older adults to help prevent the loss of muscle mass that typically occurs with advancing age.
- Conditions
- Aging
- Being tested
- Protein quantity and quality
- Keywords
- protein, plant-based, dairy, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein quantity and qualityOther
Participants will ingest Lacto-vegetarian and vegan diets providing different daily protein quantities. The parallel design will test for protein quantity and the cross-over design will compare the effects of the quality of the protein sources in the diet.
| Study group | Role | What they receive |
|---|---|---|
| RDA Lacto-Vegetarian/Vegan | Experimental | Subjects will receive diets containing the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol. Receives: Other: Protein quantity and quality |
| Higher than RDA Lacto-Vegetarian/Vegan | Experimental | Subjects will receive diets containing more than the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol. Receives: Other: Protein quantity and quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic proteome profiling (synthesis and breakdown)
Proteins from skeletal muscle samples will be extracted and fractionated by sodium dodecyl sulfate - polyacrylamide gel electrophoresis (SDS-PAGE). The gel bands corresponding to 10 discrete molecular weight regions will be excised from Coomassie blue-stained gels and digested. The peptides will be extracted from the gel for liquid chromatography-mass spectrometry (LC/MS) analysis. Protein identifications will be based on the Uniprot/Swissprot database. A visual basic application will be used to predict mass isotopomer patterns over a range of precursor body 2H2O enrichments (p) for each peptide, based on the number (n) of C-H positions in the summed amino acids in each peptide that actively incorporate 2H from body water. Fractional synthesis rates (%) of proteins will be calculated by deconvoluting the mass isotopomer pattern of newly synthesized peptide species as compared to unlabeled species and, from this, calculating the fraction of newly synthesized peptides present.
Measured: Resulting data after two weeks following a vegan and a lacto-vegetarian diet
Integrated muscle protein synthesis
Participants will ingest deuterated water for two weeks when following a vegan and a lacto-vegetarian diet according to a cross-over experimental design. Skeletal muscle biopsies will be collected before and after two weeks to return the integrated muscle protein synthesis representative of two weeks. Muscle protein synthesis data will be calculated based on the incorporation of deuterated alanine in muscle proteins. Muscle samples will be prepared for gas chromatography-mass spectrometry (GC-MS) analysis of the individual amino acids. Data obtained from GC-MS will be used to calculate integrated muscle protein synthesis (%.d-1).
Measured: Integrated total protein synthesis after two weeks following a vegan and a lacto-vegetarian diet
Whole-body protein balance
Participants will report to the lab to participate in a 2-period tracer infusion-metabolic study. Using stable isotope tracers, fasting and fed protein kinetics will be assessed. Fasting protein kinetics will be assessed during a 3.5h infusion. The fed protein balance will be assessed for 4h after consumption of a test meal at three different times during the visit. Blood samples will be collected at several time-points following tracer infusion to measure tracer enrichment. The calculation of whole-body protein kinetics (protein synthesis, protein breakdown, and net protein balance) will be based on the determinations of the rate of appearance (Ra) of phenylalanine (Phe) and tyrosine into plasma and the fractional Ra of endogenous tyrosine resulting from Phe hydroxylation. For that, will be applied a 2-pool model (g of protein.h-1).
Measured: After two weeks on an experimental diet, whole body protein balance will be measured during a day visit to the lab
Secondary outcomes (2)
Cell signaling pathways regulating protein synthesis in skeletal muscle
Phosphorylation of proteins in the Akt/mTORC1 pathway measured by SDS-page electrophoresis followed by Western-blotting (Arbitrary units).
Measured: Acute - Fed response (2h after ingestion of a test meal - this will be measured twice during the study - the response to a vegan meal and a to lacto-vegetarian meal).
Daily plasma amino acid concentration
Plasma amino acid concentrations will be analyzed via gas chromatography-mass spectrometry using the Phenomenex EZfaast amino acid analysis kit per the manufacturer's instructions (umol/L)
Measured: One day in response to 3 main meals (twice during the study - 1 day ingesting vegan meals and another day ingesting lacto-vegetarian meals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2023
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- In a partial factorial cross-over design, subjects will be assigned to one of two protein daily intakes and complete two different levels of dietary protein quality.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council, Dairy Farmers of Canada
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, PhD, Principal investigator, McMaster University, Department of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301179
- Sponsor's protocol ID
- 7929
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanistic Underpinning of Protein Quality and Quantity in Aging Skeletal Muscle: A High Sensitivity Dynamic Proteome Profiling Approach
- ClinicalTrials.gov ID
- NCT05301179
- Acronym / sponsor ID
- 7929
- Conditions
- Aging
- Keywords
- protein, plant-based, dairy, aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- National Dairy Council, Dairy Farmers of Canada
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Mar 2022 (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.
After the age of ~50, humans start to lose muscle mass at a rate of about 1-3% per year. However, the loss of muscle mass beyond a certain point can make it increasingly difficult to perform activities of daily living such as rising from a chair, going up and downstairs, carrying groceries, etc. A reason why muscle mass is lost with age is that skeletal muscles become less sensitive to the growth-promoting effects of physical activity and protein ingestion. This loss of sensitivity can be overcome by consuming larger amounts of protein; however, many older adults have difficulties simply consuming greater amounts of protein from whole-food sources. Therefore, the research in this study aims to investigate how different amounts and types of protein, of either a 100%-plant-based or Lacto-vegetarian (plant-based plus dairy) protein sources, affect muscle growth. This information will be important when providing information to older adults about the amount and type of protein that should be consumed by older adults to help prevent the loss of muscle mass that typically occurs with advancing age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a partial factorial cross-over design, subjects will be assigned to one of two protein daily intakes and complete two different levels of dietary protein quality.
| Arm | Type | Receives |
|---|---|---|
| RDA Lacto-Vegetarian/Vegan | Experimental | Other: Protein quantity and qualitySubjects will receive diets containing the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol. |
| Higher than RDA Lacto-Vegetarian/Vegan | Experimental | Other: Protein quantity and qualitySubjects will receive diets containing more than the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Be a male or female, between the ages of 65 - 80 years (inclusive)
- Be willing and able to provide informed consent
- Be in general good health, non-smoking
- Have a body mass index (BMI) between 20-35 kg/m2 (inclusive)
Key exclusion criteria (13 listed)
- Use of tobacco or related products.
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
- Use assistive walking devices (e.g., cane or walker)
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
- Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives.
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 |
|---|---|---|
| Protein quantity and qualityParticipants will ingest Lacto-vegetarian and vegan diets providing different daily protein quantities. The parallel design will test for protein quantity and the cross-over design will compare the effects of the quality of the protein sources in the diet. | Other | Higher than RDA Lacto-Vegetarian/Vegan, RDA Lacto-Vegetarian/Vegan |
Primary outcome
Dynamic proteome profiling (synthesis and breakdown)
Time frame: Resulting data after two weeks following a vegan and a lacto-vegetarian diet
Proteins from skeletal muscle samples will be extracted and fractionated by sodium dodecyl sulfate - polyacrylamide gel electrophoresis (SDS-PAGE). The gel bands corresponding to 10 discrete molecular weight regions will be excised from Coomassie blue-stained gels and digested. The peptides will be extracted from the gel for liquid chromatography-mass spectrometry (LC/MS) analysis. Protein identifications will be based on the Uniprot/Swissprot database. A visual basic application will be used to predict mass isotopomer patterns over a range of precursor body 2H2O enrichments (p) for each peptide, based on the number (n) of C-H positions in the summed amino acids in each peptide that actively incorporate 2H from body water. Fractional synthesis rates (%) of proteins will be calculated by deconvoluting the mass isotopomer pattern of newly synthesized peptide species as compared to unlabeled species and, from this, calculating the fraction of newly synthesized peptides present.
Integrated muscle protein synthesis
Time frame: Integrated total protein synthesis after two weeks following a vegan and a lacto-vegetarian diet
Participants will ingest deuterated water for two weeks when following a vegan and a lacto-vegetarian diet according to a cross-over experimental design. Skeletal muscle biopsies will be collected before and after two weeks to return the integrated muscle protein synthesis representative of two weeks. Muscle protein synthesis data will be calculated based on the incorporation of deuterated alanine in muscle proteins. Muscle samples will be prepared for gas chromatography-mass spectrometry (GC-MS) analysis of the individual amino acids. Data obtained from GC-MS will be used to calculate integrated muscle protein synthesis (%.d-1).
Whole-body protein balance
Time frame: After two weeks on an experimental diet, whole body protein balance will be measured during a day visit to the lab
Participants will report to the lab to participate in a 2-period tracer infusion-metabolic study. Using stable isotope tracers, fasting and fed protein kinetics will be assessed. Fasting protein kinetics will be assessed during a 3.5h infusion. The fed protein balance will be assessed for 4h after consumption of a test meal at three different times during the visit. Blood samples will be collected at several time-points following tracer infusion to measure tracer enrichment. The calculation of whole-body protein kinetics (protein synthesis, protein breakdown, and net protein balance) will be based on the determinations of the rate of appearance (Ra) of phenylalanine (Phe) and tyrosine into plasma and the fractional Ra of endogenous tyrosine resulting from Phe hydroxylation. For that, will be applied a 2-pool model (g of protein.h-1).
2 secondary outcomes
Cell signaling pathways regulating protein synthesis in skeletal muscle
Time frame: Acute - Fed response (2h after ingestion of a test meal - this will be measured twice during the study - the response to a vegan meal and a to lacto-vegetarian meal).
Daily plasma amino acid concentration
Time frame: One day in response to 3 main meals (twice during the study - 1 day ingesting vegan meals and another day ingesting lacto-vegetarian meals)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- 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 Phillips, PhD principal investigator
McMaster University, Department of Kinesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein quantity and quality in people with Aging, run by McMaster University at 1 site 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Dynamic proteome profiling (synthesis and breakdown) (time frame: Resulting data after two weeks following a vegan and a lacto-vegetarian diet). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024.