NCT04595188

Brief Summary

This study aims to determine the requirements for the sulphur amino acids in adults over the age of 60 years:

  1. 1.the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid.
  2. 2.the minimum methionine requirement as methionine in the presence of excess dietary cysteine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

October 6, 2020

Last Update Submit

September 11, 2023

Conditions

Keywords

elderlyamino acid requirementmethioninecysteinedietary requirementsulphur amino acids

Outcome Measures

Primary Outcomes (1)

  • Determination of total sulphur amino acid requirements in adults >60 years of age

    methionine requirement the presence of zero cysteine

    up to 24 months

Secondary Outcomes (1)

  • Determination of minimum sulphur amino acid requirements in adults >60 years of age

    up to 24 months

Study Arms (1)

Sulphur amino acids in Adults > 60

EXPERIMENTAL

Total sulphur amino acid, as methionine only: all subjects will receive up to 7 methionine test levels, without dietary cysteine, assigned in random order. Minimum methionine, with excess dietary cysteine: all subjects will receive up to 7 methionine test levels, in the presence of excess and constant dietary cysteine, assigned in random order.

Other: Sulphur amino acids

Interventions

For the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day. For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine).

Sulphur amino acids in Adults > 60

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, vitamin-B6, vitamin- B12 and folate levels within normal ranges for age.
  • 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, cancer, liver or kidney disease, acute cold or flu)
  • 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)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Paoletti A, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. The dietary requirement for total sulfur amino acids in adults aged >/=60 years appears to be higher in males than in females. Am J Clin Nutr. 2023 Sep;118(3):538-548. doi: 10.1016/j.ajcnut.2023.06.015. Epub 2023 Jun 24.

Study Officials

  • Glenda Courtney-Martin, MSc, PhD, RD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic & Clinical Specialist, Project Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 20, 2020

Study Start

October 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations