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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01943266
First received: August 16, 2013
Last updated: May 13, 2014
Last verified: May 2014
  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 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.


Condition Intervention Phase
Healthy Males 65-75 Yrs Old
Dietary Supplement: protein intake
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Male Subjects 65-75 Yrs Old.

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protein intake
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

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria:

    1. Healthy elderly males between the ages of 65 to 75 years
    2. Willingness to participate in the study
    3. Males 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. Males with hypertension if well controlled by medications

Exclusion Criteria:

  1. Presence of disease known to affect protein and amino acids (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.
  4. Individual on weight reducing diets.
  5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
  6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
  7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine)
  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: NCT01943266

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Dr. Paul Pencharz, Senior Scientist, The Research Institute, Hospital for Sick Children, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01943266     History of Changes
Other Study ID Numbers: 0019850580-C
Study First Received: August 16, 2013
Last Updated: May 13, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 14, 2014