NCT02971059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

November 14, 2016

Last Update Submit

September 14, 2018

Conditions

Older Adults

Keywords

ElderlyPhenylalanineHealthy

Outcome Measures

Primary Outcomes (1)

  • Phenylalanine Requirement

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

    Baseline

Study Arms (2)

Adult Males >65 years

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.

Dietary Supplement: Phenylalanine intake

Adult Females >65 years

EXPERIMENTAL

Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.

Dietary Supplement: Phenylalanine intake

Interventions

Phenylalanine intakeDIETARY_SUPPLEMENT

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

Adult Females >65 yearsAdult Males >65 years

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1x8, Canada

Location

Related Publications (1)

  • Martin KE, Pencharz PB, Rafii M, Ball RO, Szwiega S, Elango R, Courtney-Martin G. The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults. J Nutr. 2019 Oct 1;149(10):1776-1784. doi: 10.1093/jn/nxz137.

    PMID: 31271193DERIVED

Study Officials

  • Glenda Courtney-Martin

    Hospital for Sick Children, Toronto, Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Investigator

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 22, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)