NCT02499926

Brief Summary

This research study is investigating if consuming more of one amino acid (arginine) influences the digestion and absorption of another amino acid (lysine) due to competition in digestion, in a healthy adult population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 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

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

July 14, 2015

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 13CO2 production

    Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of tracer with graded intake of arginine

    8 hours (1 study day)

Study Arms (1)

Dietary supplement: Arginine

EXPERIMENTAL

Graded arginine excess intake

Dietary Supplement: Arginine

Interventions

ArginineDIETARY_SUPPLEMENT

Graded arginine excess intake will start at 50mg/kg/d on study day 1 followed by 100 mg/kg/d on study day 2 till the level reaches 300mg/kg/d on study day 6. Consisting of oral consumption of eight hourly experimental meals per study day - Includes 4 tracer free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.

Dietary supplement: Arginine

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • You are 19 to 50 years-of-age
  • Male
  • Classified as normal body weight and BMI (18.5-25 kg/m2)
  • Free of any concurrent illness (cold, flu, vomiting etc.)
  • Not be claustrophobic (we will place a clear hood, which can easily be removed, over your head for approximately 20 min to measure your energy expenditure).
  • Not be enrolled in any other research studies (as this may affect our study results)

You may not qualify if:

  • You are not in good health or have a metabolic, neurological, genetic, or immune disorder, including diabetes and hypertension
  • You are classified as underweight (\<18.5 kg/m2), overweight (25-30 kg/m2), or obese (\>30 kg/m2) using the BMI classification
  • You are allergic to milk, eggs and egg protein
  • You are claustrophobic (we will place a clear hood, which can easily be removed, over your head for approximately 20 min to measure your energy expenditure)
  • You are currently enrolled in other research studies (as this may affect our study results)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children;s Hospital Research Institute, University of British Columbia

Vancouver, British Columbia, V5Z4H4, Canada

Location

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Rajavel Elango, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 12, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations