Comparison of Plant and Animal Proteins on Amino Acid Concentrations

Randomized Clinical Trial in Healthy Men Evaluating the Impact of Dairy and Plant-based Protein Blends on Plasma Amino Acids

The study purpose is to assess various protein blends, which differ in protein quality, and the impact on blood amino acid response in male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Resistance-Trained Males
• Intervention / Treatment: Other: Animal Proteins (crossover); Other: Plant-based protein blends type 1 (crossover); Other: Plant-based protein blends type 2 (crossover); Other: Plant-based protein blends type 3 (crossover)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic, Index Laboratories, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy, resistance-trained adult men 18-35 years of age, inclusive, at the screening visit.
• BMI between 18.5 and 29.9 kg/m² inclusive at sceening
• Self-reported resistance training experience of no less than two years , and have participated in resistance training of at least 1h two days per week for the past six months.
• Willing to abstain from any protein supplements for 1 day prior to the study intervention phase (i.e. from the randomised visit, Visit 2)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Animal proteins (crossover)	Other: Animal Proteins (crossover); Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 1 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 2 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 3 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
Experimental: Plant-based protein blends type 1 (crossover)	Other: Animal Proteins (crossover); Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 1 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 2 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 3 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
Experimental: Plant-based protein blends type 2 (crossover)	Other: Animal Proteins (crossover); Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 1 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 2 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 3 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
Experimental: Plant-based protein blends type 3 (crossover)	Other: Animal Proteins (crossover); Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 1 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 2 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Other: Plant-based protein blends type 3 (crossover); Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma essential amino acids amounts	Following an overnight fast, blood amino acids will be measured over 4 hours	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetic response of the branch chain amino acids	Following an overnight fast, plasma branch chain amino acids amounts (area under the curve) will be measured over 4 hours at fasting	4 hours
Maximum amount of plasma branch chain amino acid amounts	The maximum plasma branch chain amino acid amount will be measured over 4 hours	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach the maximum amount of plasma branch chain amino acid amounts	The time to reach the maximum of plasma branch chain amino acid amount will be measured over 4 hours	4 hours

Collaborators and Investigators

• Sponsor: Danone North America
• Investigators: Study Chair: Jessica BRENNAN, Danone North America

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NU382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No