Lysine Requirement of Elderly Men and Women Over 60 Years of Age

NCT02008955 | Completed

• 1 other identifier: 0019850580 E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the requirement for lysine in men and women over the age of 60 years. Seven different levels of lysine intake will be tested in each subject in random order. Each level of lysine intake will involve a 3-day maintenance diet, with measures (breath, urine, and blood samples) being collected on the third.

Conditions

Healthy

Keywords

lysine, elderly, amino acid requirement, diet

Outcome Measures

Primary Outcomes (1)

• change in oxidation of phenylalanine in response to increasing lysine intake

  F13CO2

  8 hours

Secondary Outcomes (1)

• phenylalanine oxidations determined from urinary phenylalanine enrichments

  8 hrs

Study Arms (1)

lysine intake at different levels of intake

EXPERIMENTAL

all subjects will receive all 7 of the lysine test levels, assigned in random order.

Dietary Supplement: Lysine intake provided as a milkshake

Interventions

Lysine intake provided as a milkshake DIETARY_SUPPLEMENT

There are 7 different lysine test levels ranging from 10 to 80 mg of lysine per kilogram body weight per day (10 - 80 mg/kg/d)

lysine intake at different levels of intake

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• non diabetic
• not obese
• willing to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire)

You may not qualify if:

• obese (BMI greater than 30 kg/m2)
• recent history of weight loss or weight gain
• presence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
• On medications known to affect protein and amino acid metabolism (steroids)
• Inability to tolerate the diet
• Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
• Significant coffee consumption of more than 2 cups/day
• Significant alcohol consumption of more than one drink/day
• smoking

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 25320185 BACKGROUND

• Rafii M, Paoletti A, He H, Porto B, Szwiega S, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. Dietary Lysine Requirements of Older Adults Stratified by Age and Sex. J Nutr. 2024 Jul;154(7):2133-2142. doi: 10.1016/j.tjnut.2024.04.034. Epub 2024 May 11.

  PMID: 38735574 DERIVED

Study Officials

• Paul Pencharz, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, The Research Institute, Hospital for Sick Children

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

CA (1)