Assessment of Dietary Protein Needs of Older Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01193946
First received: July 27, 2010
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Protein-energy; Imbalance
Dietary Supplement: dietary control

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Dietary Protein Needs of Older Women

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • dietary protein requirement in older women [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake


Biospecimen Retention:   Samples With DNA

plasma samples


Enrollment: 8
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193946

Locations
United States, Indiana
Purdue University
W Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

No publications provided by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT01193946     History of Changes
Other Study ID Numbers: 1001008857, UL1RR025761
Study First Received: July 27, 2010
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Protein requirement
Elderly women
Indicator amino acid oxidation

ClinicalTrials.gov processed this record on September 22, 2014