Comparison of Plant and Animal Proteins on Amino Acid Concentrations

November 23, 2018 updated by: Danone North America

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma essential amino acids amounts
Time Frame: 4 hours
Following an overnight fast, blood amino acids will be measured over 4 hours
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinetic response of the branch chain amino acids
Time Frame: 4 hours
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
Time Frame: 4 hours
The maximum plasma branch chain amino acid amount will be measured over 4 hours
4 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to reach the maximum amount of plasma branch chain amino acid amounts
Time Frame: 4 hours
The time to reach the maximum of plasma branch chain amino acid amount will be measured over 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danone North America

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jessica BRENNAN, Danone North America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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