NCT07561619

Brief Summary

Protein supplementation is said to be one of the cost-efficient and practical strategies to meet protein needs for growth and exercise, and can help maximize muscle gain from resistance exercise. It facilitates faster recovery from stress-induced tissue damage and enhances performance output. Protein sources derived from animal products are generally recognized as the highest quality protein. However, altering the protein composition of a protein source can improve the protein quality. The yeast protein supplement we will use in this study has a similar amino acid composition to whey protein, which is derived from an animal product, but it is produced more sustainably. Our study aims to compare the effects of yeast and whey protein on muscle mass over 16 weeks.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
37mo left

Started Jul 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in muscle mass

    The primary outcome of the study is the change in muscle mass. It is hypothesized that participants consuming yeast protein will show an increase in appendicular lean mass similar to that observed with whey protein.

    16 weeks

Secondary Outcomes (1)

  • Changes in muscle function, inflammatory biomarkers, oxidative stress markers, gut microbiota and metabolites

    16 weeks

Study Arms (2)

Whey Protein

ACTIVE COMPARATOR
Other: Resistance Training ExercisesDietary Supplement: Whey Protein

Yeast Protein

EXPERIMENTAL
Dietary Supplement: Yeast ProteinOther: Resistance Training Exercises

Interventions

Yeast ProteinDIETARY_SUPPLEMENT

60g of protein supplement (40g of protein). Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.

Yeast Protein

Lower and upper body resistance training exercises 3 times a week for 16 weeks

Whey ProteinYeast Protein
Whey ProteinDIETARY_SUPPLEMENT

60g of protein supplement (40g of protein). Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.

Whey Protein

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
  • Prior resistance training experience (defined as performing resistance exercises \>1/week for the past 3 months or longer) to enable them to reach a large training stimulus relatively quickly and to avoid the longer phase of neuromuscular adaptations
  • ≥18 years and \<35 years of age

You may not qualify if:

  • Diabetes, musculoskeletal disease, cancer, Crohn's disease, or any other acute or chronic condition that interferes (or the medication prescribed for those conditions) with muscle anabolism.
  • Diagnosed with or being treated for heart disease, stroke, high blood pressure 130/80 mmHg or higher
  • Pain/discomfort/pressure in the chest during activities of daily living or physical activity
  • Pregnant or not on adequate contraception.
  • A known hypersensitivity/allergy to ingredients in the supplements.
  • Inflammatory bowel diseases
  • Enrolment in any other clinical protocol or investigational study that may interfere with study procedures
  • Taking antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alberta North Campus

Edmonton, Alberta, T6G 2R3, Canada

Location

Related Publications (6)

  • West DWD, Abou Sawan S, Mazzulla M, Williamson E, Moore DR. Whey Protein Supplementation Enhances Whole Body Protein Metabolism and Performance Recovery after Resistance Exercise: A Double-Blind Crossover Study. Nutrients. 2017 Jul 11;9(7):735. doi: 10.3390/nu9070735.

    PMID: 28696380BACKGROUND
  • Patel S. Emerging trends in nutraceutical applications of whey protein and its derivatives. J Food Sci Technol. 2015 Nov;52(11):6847-58. doi: 10.1007/s13197-015-1894-0. Epub 2015 Jun 9.

    PMID: 26884639BACKGROUND
  • Norton LE, Wilson GJ, Layman DK, Moulton CJ, Garlick PJ. Leucine content of dietary proteins is a determinant of postprandial skeletal muscle protein synthesis in adult rats. Nutr Metab (Lond). 2012 Jul 20;9(1):67. doi: 10.1186/1743-7075-9-67.

    PMID: 22818257BACKGROUND
  • Joy JM, Lowery RP, Wilson JM, Purpura M, De Souza EO, Wilson SM, Kalman DS, Dudeck JE, Jager R. The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance. Nutr J. 2013 Jun 20;12:86. doi: 10.1186/1475-2891-12-86.

    PMID: 23782948BACKGROUND
  • Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.

    PMID: 23134885BACKGROUND
  • Banaszek A, Townsend JR, Bender D, Vantrease WC, Marshall AC, Johnson KD. The Effects of Whey vs. Pea Protein on Physical Adaptations Following 8-Weeks of High-Intensity Functional Training (HIFT): A Pilot Study. Sports (Basel). 2019 Jan 4;7(1):12. doi: 10.3390/sports7010012.

    PMID: 30621129BACKGROUND

MeSH Terms

Interventions

Fungal ProteinsWhey Proteins

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Jianping Wu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Only researchers who have the training and experience to do the research (also known as "qualified researchers") will be allowed to use the data. IPD collected throughout the trail will be shared on request and with ethics approval after the study results have been accepted and published

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available for 15 yrs

Locations