## Protocol Section
### Identification Module
**NCT ID:** NCT06431334

**Brief Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique

**Official Title:** Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique

#### Organization Study ID Info
**ID:** A06-M25-23A
#### Organization
**Class:** OTHER
**Full Name:** McGill University
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** McGill University

#### Responsible Party

**Investigator Affiliation:** McGill University

**Investigator Full Name:** Tyler Churchward-Venne

**Investigator Title:** Assistant Professor of Exercise Physiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested.

Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations.

Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations.

The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.

### Conditions Module

**Conditions:**

- Healthy

- Increased Metabolic Requirements

- Dietary Reference Intakes

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 8

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants are to be randomly assigned varying levels of amino acid intakes ranging between 0.5 to 2.8 g/kg/d

**Intervention Names:**

- Dietary Supplement: Amino Acid Intake

**Label:** Masters Level Cyclists

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Masters Level Cyclists

**Description:** Amino acid intakes will vary between 0.5 to 2.8 g/kg/d

**Name:** Amino Acid Intake

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Measured by continuous-flow isotope ratio mass spectrometry

**Measure:** 13CO2 Excretion

**Time Frame:** 7-weeks

#### Secondary Outcomes

**Description:** Measured by gas chromatography-mass spectrometry

**Measure:** L[13C]phenylalanine Oxidation

**Time Frame:** 7-weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18.5\< BMI \<35 kg/m\^2
* Overtly healthy masters level cyclists ≥65 years
* Masters level cyclist training (\>4 days per week; \~100 km per week)
* Body mass stable over previous 6-months
* Availability for multiple metabolic trials (\~7 trials)
* Ability to travel to and from laboratory facility

Exclusion Criteria:

* Recent history of weight loss or weight gain (\>5% body weight)
* Uncontrolled hypertension
* ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia)
* Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza)
* Currently using anti-inflammatory medications
* Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions)
* Regular tobacco user
* Illicit drug use
* Habitually ingesting ≥3 g/kg/bw

**Healthy Volunteers:** True

**Minimum Age:** 65 Years

**Sex:** MALE

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tyler.churchward-venne@mcgill.ca

**Name:** Tyler A. Churchward-Venne, Ph.D.

**Phone:** (514) 398-4184

**Phone Ext:** 00839

**Role:** CONTACT

**Contact 2:**

**Email:** zachary.bell2@mcgill.ca

**Name:** Zachary Bell, Ph.D

**Phone:** (514) 296-6960

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Montréal

**Contacts:**

***Contact 1:***

- **Email:** zachary.bell2@mcgill.ca

- **Name:** Zachary W Bell, PhD

- **Phone:** 5142966960

- **Role:** CONTACT

***Contact 2:***

- **Email:** tyler.churchward-venne@mcgill.ca

- **Name:** Tyler A Churchward-Venne, PhD

- **Phone:** 5147938920

- **Role:** CONTACT

***Contact 3:***

- **Name:** Zachary W Bell, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Tyler A Churchward-Venne, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Micaela Forcione, BSc

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** McGill University

**State:** Quebec

**Zip:** H3A 0G4

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
