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

Not Applicable

Completed

• Conditions: Healthy Females; Protein Requirement
• Interventions: Dietary Supplement: Protein intake.

• Registration Number: NCT01604980
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

1. Healthy elderly females >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.
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) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protein Intakes	Protein intake.	subjects will recieve differnt levels of protein intakes varying from 0.2 to2.0g/kg/day.

Primary Outcome Measures

Name	Time	Method
13CO2 Production	Study Day 3	Urine and breath samples will be collected on day 3 of the experiment to determine the rate of production

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada