Lysine Requirements of Elderly Female Subjects 65-75 Years Old.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02008955
First received: December 8, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The lysine requirement of elderly female subjects 65-75 years old will be 40-45 mg/kg/day.


Condition Intervention
Lysine Requirement in Elderly Female Subjects
Dietary Supplement: Lysine intake provided as a milkshake

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • change in oxidation of phenylalanine in response to increasing lysine intake [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    F13CO2


Secondary Outcome Measures:
  • phenylalanine oxidations determined from urinary phenylalanine enrichments [ Time Frame: 8 hrs ] [ Designated as safety issue: No ]
    phenylalanine oxidation (phe OX)


Enrollment: 13
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lysine intake at different levels of intake Dietary Supplement: Lysine intake provided as a milkshake

Detailed Description:

Currently there are no studies on lysine requirement in the elderly.

The goal of this study therefore is to measure the lysine requirement of female elderly subjects 65-75 years using the IAAO technique.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:65-75 years old, non diabetic, not obese, willing to participate in the study.

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Exclusion Criteria:diabetes, obese.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02008955

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Dr. Paul Pencharz, Senior Scientist, The Research Institute, Hospital for Sick Children, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02008955     History of Changes
Other Study ID Numbers: 0019850580 E
Study First Received: December 8, 2013
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
lysine, indicator amino acid oxidation, elderly females

ClinicalTrials.gov processed this record on September 16, 2014