Determination of Protein Requirement in Elderly Male Subjects >75 Yrs Old

This study is currently recruiting participants.
Verified September 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01948492
First received: August 16, 2013
Last updated: September 18, 2013
Last verified: September 2013
  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 intake (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, 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 > 75 years using the indicator amino acid oxidation (IAAO) technique.

Hypothesis:

The investigators hypothesize the protein requirement in elderly male subjects will be lower (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).


Condition Intervention Phase
Healthy Male Subjects 65-75 Years Old.
Dietary Supplement: Protein intake
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

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

Primary Outcome Measures:
  • Breath samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal. The ratios of carbon 13 to carbon 12 will be measured in breath. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal for measurement of the rations of the enrichment of carbon 13 to carbon 12 in urine phenylalanine. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protein
varying protein intake in random order 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 intakes will be varied as 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, 2.0 g/kg/day.

  Eligibility

Ages Eligible for Study:   76 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy elderly males >75 years
  2. Willingness to participate in the study
  3. Males without a chronic disease or acute illness that could affect protein and amino acid (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948492

Contacts
Contact: Glenda Courtney-Martin, PhD, RD 416-813-5744 glenda.courtney-martin@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Glenda Courtney-Martin, PhD, RD    416-843-5744    glenda.courtney-martin@sickkids.ca   
Principal Investigator: Paul Pencharz, MD, PhD         
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: NCT01948492     History of Changes
Other Study ID Numbers: 0019850580-D
Study First Received: August 16, 2013
Last Updated: September 18, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on April 15, 2014