An interventional study of protein intake in Healthy Males 65-75 Yrs Old, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to male participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Other
Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.
The current dietary reference intakes (DRI) requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).
Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by national health and nutrition examination survey (NHANES), the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.
The goal of this study therefore is to measure the protein requirement of male elderly subjects between the ages of 65 - 75 years using the IAAO technique.
The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Healthy elderly males between the ages of 65 to 75 years
Exclusion Criteria:
protein intake randomly fed from deficient to excess
Dietary Supplement: protein intake
on the study day, the diet will be provided as free amino acids,with calories made up by a liquid diet and protein free cookies. Protein intake will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, and 2.0 g.kg/day
Urine (for measurement of 13C phenylalanine enrichment) and breath (for measurement of 13CO2 enrichment) samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal.
Time frame: 10 months
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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