Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old
|ClinicalTrials.gov Identifier: NCT01604980|
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : January 9, 2018
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 >75 years using the IAAO technique.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Females Protein Requirement||Dietary Supplement: Protein intake.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Female Subjects >75 Years Old|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Protein Intakes
subjects will recieve differnt levels of protein intakes varying from 0.2 to2.0g/kg/day.
Dietary Supplement: Protein intake.
protein intakes will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8 and 2.0g/kg/day
- 13CO2 Production [ Time Frame: Study Day 3 ]Urine and breath samples will be collected on day 3 of the experiment to determine the rate of production
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604980
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Paul Pencharz, MD||The Hospital for Sick Children|