Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  Purpose

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 Intervention
Healthy
 Dietary Supplement: protein intake.

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.
Enrollment: 14
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   65 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578733

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Paul Pencharz, MD The Hospital for Sick Children
  More Information

Responsible Party: Dr. Paul Pencharz, Senior Sicentist, Research Institute, The Hospital for Sick Children, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01578733     History of Changes
Other Study ID Numbers: 0019850580-A 
Study First Received: April 3, 2012
Last Updated: August 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
protein requirement
female elderly
healthy female subject's protein requirements

ClinicalTrials.gov processed this record on September 26, 2016