Assessment of Dietary Protein Needs of Older Women

January 16, 2013 updated by: Wayne Campbell, Purdue University

The purpose of this study is to evaluate dietary protein requirements in elderly women aged 80 years and older using the indicator amino acid oxidation technique.

Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • W Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female Age range: 80 yrs and older Body mass index between 22-30 Weight stable 4.5 kg weight gain or loss within the last 6 month Non-smoking within the last 6 month Ambulatory Clinically normal blood profiles within 10% of clinical normalcy. No diseases or not taking medications known to influence protein or energy metabolism, Willingness and ability to consume food provided and not allergic to phenylalanine

Description

Inclusion Criteria:

  • Female
  • Age range: 80 yrs and older
  • Body mass index between 22-30
  • Weight stable 4.5 kg weight gain or loss within the last 6 month
  • Non-smoking within the last 6 month
  • Ambulatory
  • Clinically normal blood profiles within 10% of clinical normalc.
  • No diseases or not taking medications known to influence protein or energy metabolism,
  • Willingness and ability to consume food provided and not allergic to phenylalanine
  • Continent, strong bladder control

Exclusion Criteria:

  • Male,
  • Gained or lost more than 4.5 kg of body weight within the last 6 months,
  • Non-ambulatory (i.e. bedridden, wheel-chair bound),
  • Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single-arm design
There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research
Dietary supplement: dietary control
Seven dietary protein levels will be tested randomly on the 7 testing days: 0.10, 0.30, 0.60, 0.90, 1.2, 1.5, and 1.8 g∙kg-1∙d-1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dietary protein requirement in older women
Time Frame: 3 month
Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

National Center for Research Resources (NCRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1001008857
  • UL1RR025761 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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