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

NCT ID: NCT01578733

Last Updated: 2013-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

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 between the ages of 65 - 70 years using the IAAO technique.

Conditions

Healthy

Keywords

protein requirement; female elderly; healthy female subject's protein requirements

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

protein intake

different levels of protein intake

Group Type: EXPERIMENTAL

protein intake.

Intervention Type: DIETARY_SUPPLEMENT

•Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0, 1.2, 1.5, 1.8g, 2.0g/kg/day

Interventions

protein intake.

•Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0, 1.2, 1.5, 1.8g, 2.0g/kg/day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy elderly females between the ages of 65 to 75 and >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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Dr. Paul Pencharz

Senior Sicentist, Research Institute, The Hospital for Sick Children

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Pencharz, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

0019850580-A

Identifier Type: -

Identifier Source: org_study_id