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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02008955
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Lysine Requirement in Elderly Female Subjects 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : September 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: lysine intake at different levels of intake Dietary Supplement: Lysine intake provided as a milkshake

Outcome Measures

Primary Outcome Measures :
  1. change in oxidation of phenylalanine in response to increasing lysine intake [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. phenylalanine oxidations determined from urinary phenylalanine enrichments [ Time Frame: 8 hrs ]
    phenylalanine oxidation (phe OX)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Exclusion Criteria:diabetes, obese.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008955

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

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
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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