Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old

NCT01604980 | Completed

• 1 other identifier: 0019850580-B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Females; Protein Requirement

Outcome Measures

Primary Outcomes (1)

• 13CO2 Production

  Urine and breath samples will be collected on day 3 of the experiment to determine the rate of production

  Study Day 3

Study Arms (1)

Protein Intakes

EXPERIMENTAL

subjects will recieve differnt levels of protein intakes varying from 0.2 to2.0g/kg/day.

Dietary Supplement: Protein intake.

Interventions

Protein intake. DIETARY_SUPPLEMENT

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

Protein Intakes

Eligibility Criteria

• Age: 76 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy elderly females \>75 years
• Willingness to participate in the study
• 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.
• Females with hypertension if well controlled by medications -

You may not qualify if:

• 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.
• On medications known to affect protein and amino acid metabolism like e.g. steroids.
• Significant weight loss during the past month.
• Individual on weight reducing diets.
• Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
• Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
• Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine) -

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• Rafii M, Chapman K, Owens J, Elango R, Campbell WW, Ball RO, Pencharz PB, Courtney-Martin G. Dietary protein requirement of female adults >65 years determined by the indicator amino acid oxidation technique is higher than current recommendations. J Nutr. 2015 Jan;145(1):18-24. doi: 10.3945/jn.114.197517. Epub 2014 Oct 15.

  PMID: 25320185 BACKGROUND

Study Officials

• Paul Pencharz, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, The Research Institute, Hospital for Sick Children

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CA (1)