Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01578733
First received: April 3, 2012
Last updated: August 16, 2013
Last verified: August 2013

April 3, 2012
August 16, 2013
November 2011
August 2012   (final data collection date for primary outcome measure)
13CO2 production [ Time Frame: Study Day 3 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01578733 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old
Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Female Subjects 65-75 Yrs Old

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.

Not Provided
Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Healthy
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
Experimental: protein intake
different levels of protein intake
Intervention: Dietary Supplement: protein intake.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy elderly females between the ages of 65 to 75 and >75 years
  2. Willingness to participate in the study
  3. Females without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  4. Females with hypertension if well controlled by medications

Exclusion Criteria:

  1. Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
  3. Significant weight loss during the past month.
Female
65 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01578733
0019850580-A
No
Dr. Paul Pencharz, The Hospital for Sick Children
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Paul Pencharz, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP