Clinical trial NCT01193946: Assessment of Dietary Protein Needs of Older Women
Official title: Assessment of Dietary Protein Needs of Older Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Protein-energy; Imbalance
Keywords: Protein requirement
Elderly women
Indicator amino acid oxidation
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-09-02
Enrollment: 8
Sex: FEMALE
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: dietary protein requirement in older women
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: W Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.