Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old
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|ClinicalTrials.gov Identifier: NCT01578733|
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : August 19, 2013
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 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 IAAO, the investigators 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 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 female elderly subjects between the ages of 65 - 70 years using the IAAO technique.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: protein intake.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Female Subjects 65-75 Yrs Old|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: protein intake
different levels of protein intake
Dietary Supplement: protein intake.
•Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0, 1.2, 1.5, 1.8g, 2.0g/kg/day
- 13CO2 production [ Time Frame: Study Day 3 ]Urine and breath samples will be collected on day 3 of the experiment in order to determine to rate of production of 13CO2, phenylalanine flux and oxidation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578733
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Paul Pencharz, MD||The Hospital for Sick Children|