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Completed

NCT Number: NCT02971059

Phenylalanine Requirement of Adults >65 Years.

Currently there are insufficient published studies on amino acid requirements in the elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been observed in in the blood of older adults. It is due the increased uptake by the liver and intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle protein synthesis. Requirement for elderly individuals have been set based on studies conducted in younger adults hence may be inaccurate. The goal of this study is to directly measure the phenylalanine requirement of male and female elderly subjects over 65 years using the direct amino acid oxidation (DAAO) technique.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1x8, Canada

About this study

  • To determine and compare the phenylalanine requirement of healthy elderly male and female adults over the age of 65 years using the DAAO technique (by measuring the oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] ) in response to graded intakes of phenylalanine.
  • To compare the requirement so derived to that of young healthy adult previously determined in our lab.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy elderly males and females > 65 years
  • Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
  • No recent history of weight loss
  • Absence 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.
  • Non-smoking
  • Willingness to consume the diet provided

Exclusion criteria

  • Presence of disease known to 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).
  • Recent significant weight loss.
  • Individual on weight reducing diets.
  • 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

Treatment and study plan

Phenylalanine intake

Dietary Supplement

Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day

Primary outcomes

  1. Phenylalanine Requirement

    Time frame: Baseline

    To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Phenylalanine Requirement of Healthy Older Adult Males and Females > 65 Years Determined by Direct Amino Acid Oxidation (DAAO) Method.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2016
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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