Healthy Resistance-Trained MalesNCT03673839
Comparison of Plant and Animal Proteins on Amino Acid Concentrations
A study testing Animal Proteins (crossover), Plant-based protein blends type 1 (crossover) and Plant-based protein blends type 2 (crossover) in people with Healthy Resistance-Trained Males, run by Danone North America at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Resistance-Trained Males
- What is being tested?
- Animal Proteins (crossover), Plant-based protein blends type 1 (crossover) and Plant-based protein blends type 2 (crossover)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2018to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Resistance-Trained Males
- Being tested
- Animal Proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover), Plant-based protein blends type 3 (crossover)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Proteins (crossover)Other
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)Other
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)Other
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)Other
Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
| Study group | Role | What they receive |
|---|---|---|
| Animal proteins (crossover) | Active comparator | Not described Receives: 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) |
| Plant-based protein blends type 1 (crossover) | Experimental | Not described Receives: 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) |
| Plant-based protein blends type 2 (crossover) | Experimental | Not described Receives: 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) |
| Plant-based protein blends type 3 (crossover) | Experimental | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma essential amino acids amounts
Following an overnight fast, blood amino acids will be measured over 4 hours
Measured: 4 hours
Secondary outcomes (2)
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
Measured: 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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start20 Sep 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Resistance-Trained MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica BRENNAN, Study chair, Danone North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673839
- Sponsor's protocol ID
- NU382
- Status last verified
- Nov 2018
- First submitted
- 14 Sep 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial in Healthy Men Evaluating the Impact of Dairy and Plant-based Protein Blends on Plasma Amino Acids
- ClinicalTrials.gov ID
- NCT03673839
- Acronym / sponsor ID
- NU382
- Conditions
- Healthy Resistance-Trained Males
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Danone North AmericaIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Animal proteins (crossover) | Active comparator | 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) |
| Plant-based protein blends type 1 (crossover) | Experimental | 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) |
| Plant-based protein blends type 2 (crossover) | Experimental | 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) |
| Plant-based protein blends type 3 (crossover) | Experimental | 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Animal proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover), Plant-based protein blends type 3 (crossover) |
| 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 | Animal proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover), Plant-based protein blends type 3 (crossover) |
| 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 | Animal proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover), Plant-based protein blends type 3 (crossover) |
| 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 | Other | Animal proteins (crossover), Plant-based protein blends type 1 (crossover), Plant-based protein blends type 2 (crossover), Plant-based protein blends type 3 (crossover) |
Primary outcome
Plasma essential amino acids amounts
Time frame: 4 hours
Following an overnight fast, blood amino acids will be measured over 4 hours
2 secondary outcomes
Kinetic response of the branch chain amino acids
Time frame: 4 hours
Maximum amount of plasma branch chain amino acid amounts
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica BRENNAN study chair
Danone North America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Proteins (crossover), Plant-based protein blends type 1 (crossover) and Plant-based protein blends type 2 (crossover) in people with Healthy Resistance-Trained Males, run by Danone North America at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma essential amino acids amounts (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.