Skip to main content
OpenTrials
Completed

NCT Number: NCT01193946

Assessment of Dietary Protein Needs of Older Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

80 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

dietary control

Dietary Supplement

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 2, 2010
Registry last updated
Jan 17, 2013

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.