NCT06283706

Brief Summary

The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress. The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 21, 2024

Last Update Submit

May 23, 2025

Conditions

Keywords

elderlyhealthytryptophan requirementindicator amino acid oxidationstable isotopes

Outcome Measures

Primary Outcomes (1)

  • Determination of tryptophan requirement in adults >60 years of age.

    To measure the tryptophan requirement investigators will collect breath samples from participants. From these samples, investigators will measure the amount of amino acids oxidized and how much is retained in the body when graded intakes of tryptophan are consumed by the participants consuming a controlled diet.

    up to 24 months

Study Arms (1)

Tryptophan in Adults >60y

EXPERIMENTAL

Tryptophan levels, up to 7 levels, will be tested in a random order in all subjects

Other: Tryptophan

Interventions

There are 7 different tryptophan test levels ranging from 0.5, 2, 4, 6, 8, 10, 12 mg.kg-1.day.1

Tryptophan in Adults >60y

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent provided.
  • Aged 60 to 90 years old.
  • In good general health as evidenced by medical history, physical health and blood draw.
  • Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine.
  • Willingness to participate in the study.
  • BMI \<30 kg/m2.

You may not qualify if:

  • Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, taking medications known to affect protein/AA metabolism (e.g. steroids).
  • Inability to tolerate the diet (i.e. allergy).
  • Significant weight loss during the past month or consumption of weight reducing diets.
  • Significant caffeine consumption (\>2 cups per day).
  • Significant consumption of alcohol (\>1 drink per day i.e. 1 beer or ½ glass of wine).
  • Unwilling to have blood drawn from a venous access or using a ventilated hood indirect calorimeter for the purposes of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Glenda Courtney-Martin, PhD, RD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahroukh Rafii, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Scientist

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

June 1, 2024

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

May 30, 2025

Record last verified: 2025-03

Locations