NCT05139160

Brief Summary

The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

November 9, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

November 9, 2021

Last Update Submit

October 6, 2024

Conditions

Keywords

plant-based proteinwhey proteinprotein qualitymuscle protein synthesis

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    A marker of muscle growth

    Over a 5 hour period

Secondary Outcomes (5)

  • Aminoacidemia

    Over a 5 hour period

  • Appetite and desire for specific food types in response to test drinks types H

    Immediately before, and 30, 60, 120, 180 and 300 minutes after test drinks are consumed.

  • Palatability of test drinks

    Immediately after test drink are consumed.

  • Questionnaire on safety

    Over a 5 hour period

  • Tolerability of test drinks

    Over a 5 hour period

Study Arms (3)

Whey protein isolate

EXPERIMENTAL

Whey protein isolate is the 'gold standard' of protein supplements due to being rich in essential amino acids and leucine. Leucine is a key amino acid the is required to stimulate muscle protein synthesis. Muscle protein synthesis is the major mechanism the underpins muscle growth. The whey protein would ostensibly serve as a positive control.

Dietary Supplement: Protein quality

Plant based protein isolate

EXPERIMENTAL

Current plant-based protein isolates available contain insufficient amounts of leucine, and are less digestible, resulting in a reduced muscle protein synthesis responses. The plant based protein would ostensibly serve as a negative control.

Dietary Supplement: Protein quality

Plant based protein isolate + leucine

EXPERIMENTAL

Enriching plant-based protein with leucine will increase the 'quality' of said protein source and theoretically should have similar muscle protein synthetic responses to whey protein.

Dietary Supplement: Protein quality

Interventions

Protein qualityDIETARY_SUPPLEMENT

the present investigation aims to study a novel protein based protein isolate blend with and without leucine an compared with whey protein isolate to determine its impact aminoacidemia and muscle protein synthesis healthy adults.

Plant based protein isolatePlant based protein isolate + leucineWhey protein isolate

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, between the ages of 18 - 30 years (inclusive)
  • Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
  • Be in general good health as assessed by a general health questionnaire
  • Non-smoking
  • Regular menstrual cycle and not using hormonal contraceptives
  • Willing and able to provide informed consent

You may not qualify if:

  • Currently using analgesic or anti-inflammatory drugs
  • A history of neuromuscular problems or muscle and/or bone wasting diseases
  • Any acute or chronic illness, metabolic disorders
  • Currently using corticosteroids
  • Use of hormonal contraceptives or anabolic steroids (e.g. testosterone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhyun Lim

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Lim C, Janssen TAH, Currier BS, Paramanantharajah N, McKendry J, Abou Sawan S, Phillips SM. Muscle Protein Synthesis in Response to Plant-Based Protein Isolates With and Without Added Leucine Versus Whey Protein in Young Men and Women. Curr Dev Nutr. 2024 May 10;8(6):103769. doi: 10.1016/j.cdnut.2024.103769. eCollection 2024 Jun.

Study Officials

  • Stuart Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study design will be a randomized, double blind, crossover trial.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study design will be a randomized, double blind, crossover trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2021

First Posted

December 1, 2021

Study Start

August 15, 2022

Primary Completion

April 1, 2023

Study Completion

July 10, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations