Assessment of Dietary Protein Needs of Older Women

NCT ID: NCT01193946

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Protein-energy; Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 control

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Wayne Campbell, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Tang M, McCabe GP, Elango R, Pencharz PB, Ball RO, Campbell WW. Assessment of protein requirement in octogenarian women with use of the indicator amino acid oxidation technique. Am J Clin Nutr. 2014 Apr;99(4):891-8. doi: 10.3945/ajcn.112.042325. Epub 2014 Jan 15.

Reference Type DERIVED
PMID: 24429540 (View on PubMed)

Other Identifiers

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UL1RR025761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1001008857

Identifier Type: -

Identifier Source: org_study_id

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