Determination of Protein Requirements in Elderly Female Subjects >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 >75 years using the IAAO technique.

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Key information

Conditions

Healthy Females Protein Requirement

Age range

76 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

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) -

Treatment and study plan

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

Primary outcomes

13CO2 Production

Time frame: Study Day 3

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Female Subjects >75 Years Old

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: May 24, 2012
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed