NCT01193946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

July 27, 2010

Last Update Submit

January 16, 2013

Conditions

Protein-energy; Imbalance

Keywords

Protein requirementElderly womenIndicator amino acid oxidation

Outcome Measures

Primary Outcomes (1)

  • dietary protein requirement in older women

    Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake

    3 month

Study Arms (1)

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 Supplement: dietary control

Interventions

dietary controlDIETARY_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.

Single-arm design

Eligibility Criteria

Age80 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 24429540DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma samples

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph.D.

Study Record Dates

First Submitted

July 27, 2010

First Posted

September 2, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)