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CompletedNCT01604980Updated Jan 9, 2018

Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old

An interventional study of Protein intake. in Healthy Females and Protein Requirement, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to female participants aged 76 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
76 Years to 90 Years
Sex
Female
01

Study summary

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current DRI requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of female elderly subjects >75 years using the IAAO technique.

02

Conditions studied

  • Healthy Females
  • Protein Requirement
03

In context

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
76 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy elderly females >75 years
  2. Willingness to participate in the study
  3. Females without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  4. Females with hypertension if well controlled by medications -

Exclusion criteria

Exclusion Criteria:

  1. Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
  3. Significant weight loss during the past month.
  4. Individual on weight reducing diets.
  5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
  6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
  7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine) -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Protein Intakes

    subjects will recieve differnt levels of protein intakes varying from 0.2 to2.0g/kg/day.

    Dietary Supplement: Protein intake.

Interventions

  • Dietary supplementProtein intake.

    protein intakes will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8 and 2.0g/kg/day

06

What researchers measure

Primary outcomes

  1. 13CO2 Production

    Urine and breath samples will be collected on day 3 of the experiment to determine the rate of production

    Time frame: Study Day 3

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G1X8, Canada
08

References and documents

Publications

  • Rafii M, Chapman K, Owens J, Elango R, Campbell WW, Ball RO, Pencharz PB, Courtney-Martin G. Dietary protein requirement of female adults >65 years determined by the indicator amino acid oxidation technique is higher than current recommendations. J Nutr. 2015 Jan;145(1):18-24. doi: 10.3945/jn.114.197517. Epub 2014 Oct 15. PubMed 25320185 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01604980
Lead sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Dr. Paul Pencharz (Senior Scientist, The Research Institute, Hospital for Sick Children, The Hospital for Sick Children) — Principal investigator
First posted
May 24, 2012
Start date
Mar 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jan 9, 2018

Study contacts

Paul Pencharz, MD
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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