Assessment of Dietary Protein Needs of Older Women

Completed

• Conditions: Protein-energy; Imbalance
• Interventions: Dietary Supplement: dietary control

• Registration Number: NCT01193946
• Lead Sponsor: Purdue University

Brief 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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-arm design	dietary control	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

Primary Outcome Measures

Name	Time	Method
dietary protein requirement in older women	3 month	Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake

Trial Locations

Locations (1)

Purdue University; 🇺🇸 W Lafayette, Indiana, United States