Assessment of Dietary Protein Needs of Older Women

Protein-energy; Imbalance Clinical Trial

Official title:

Assessment of Dietary Protein Needs of Older Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193946
• Other study ID #: 1001008857
• Secondary ID: UL1RR025761
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: January 16, 2013
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 80 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Protein-energy; Imbalance

Intervention

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.

Locations

Country	Name	City	State
United States	Purdue University	W Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dietary protein requirement in older women	Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake	3 month	No