Protein Requirements In Active Female Populations | NCT02626429

Studies
Protein Requirements In Active Female Populations

NCT02626429

Sponsor

University of Toronto

Status

Completed

Last Update Posted

Dec 11, 2017Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Increased Metabolic Requirement
Healthy

Interventions

Amino acid intake

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Dec 7, 2015

First Posted Date

Dec 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2017

Last Update Posted Date

Dec 11, 2017Actual

Name	Class
Ajinomoto Co., Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active, Young Adult Famale	Experimental	Participants will complete a bout of exercise and then consume a randomly assigned amino acid intake prior to measuring whole body 13CO2 excretion and phenylalanine oxidation.	Dietary Supplement: Amino acid intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amino acid intake	Dietary Supplement	Amino acid intakes will be varied at 0.2-2.6 g/kg/day	Active, Young Adult Famale

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
13CO2 (carbon dioxide) excretion (μmol/kg/h)		4 hours / study day

Secondary Outcomes

Measure	Description	Time Frame
13C-Phenylalanine Oxidation (μmol/kg/h)		4 hours / study day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

Exclusion Criteria:

Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
Regular tobacco use
Illicit drug use

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided