Comparison of Plant and Animal Proteins on Amino Acid Concentrations

Healthy Resistance-Trained Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673839
• Other study ID #: NU382
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: November 2018
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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:

Related Conditions & MeSH terms

• Healthy Resistance-Trained Males

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Canada	Glycemic, Index Laboratories, Inc.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Danone North America

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Plasma essential amino acids amounts	Following an overnight fast, blood amino acids will be measured over 4 hours	4 hours
Secondary	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
Secondary	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