An interventional study of Protein quantity and quality in Aging, sponsored by McMaster University. Active, not recruiting at 1 site in Canada. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by McMaster University · Not applicable, Interventional, and Basic science
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.
McMaster University is the lead sponsor of 720 studies on the registry; 123 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Subjects will receive diets containing the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol.
Other: Protein quantity and quality
Subjects will receive diets containing more than the RDA for protein from Lacto-vegetarian and Vegan sources in different periods during the protocol.
Other: Protein quantity and quality
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: After two weeks on an experimental diet, whole body protein balance will be measured during a day visit to the lab
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).
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
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)
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)
Plan to share: No
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This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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