Amino AcidsNCT04144114
The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
A study testing ProHydrolase® and Whey protein in people with Amino Acids, run by Deerland Enzymes at 1 site in United States.
Trial summary
To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acids
- What is being tested?
- ProHydrolase® and Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 7 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • At least one-year of resistance training experience
- Free of any physical limitations (determined by health and activity questionnaire).
- Between the ages of 18 and 35.
- Ability to leg press a weight equivalent to 1.5 times their body mass
Who cannot join
- • Inability to perform physical exercise (determined by health and activity questionnaire)
- Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
- Physical injury preventing the athlete from participating in offseason training
- Any chronic illness that causes continuous medical care
Trial locations and contacts
1 site in 1 country.
About this study
To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL). To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway. To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.
- Conditions
- Amino Acids
- Being tested
- ProHydrolase®, Whey protein, Placebo
- Keywords
- Amino Acids, Intramuscular Anabolic Signaling, Endocrine Response, Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProHydrolase®Dietary supplement
Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink
Whey proteinDietary supplement
Subjects received 25g of whey protein powder mixed to together in a drink
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Whey + ProHydrolase® | Experimental | Subjects received 250mg of ProHydrolase® along with 25g of whey protein mixed in a drink every visit for 4 weeks Receives: Dietary Supplement: ProHydrolase® |
| Whey | Active comparator | Subjects received 25g whey protein in a drink every visit for 4 weeks Receives: Dietary Supplement: Whey protein |
| Placebo | Placebo comparator | Subjects received 25g maltodextrin in a drink every visit for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid absorption
To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL)
Measured: 4 weeks
mTORC1 pathway
To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway
Measured: 4 weeks
Endocrine markers
To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Aug 2018
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino AcidsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deerland Enzymes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lipscomb University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144114
- Sponsor's protocol ID
- Pro18
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
- ClinicalTrials.gov ID
- NCT04144114
- Acronym / sponsor ID
- Pro18
- Conditions
- Amino Acids
- Keywords
- Amino Acids, Intramuscular Anabolic Signaling, Endocrine Response, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Deerland EnzymesIndustry (pharma, biotech, devices)
- Collaborators
- Lipscomb University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 30 Oct 2019 (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.
To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL). To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway. To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey + ProHydrolase® | Experimental | Dietary Supplement: ProHydrolase®Subjects received 250mg of ProHydrolase® along with 25g of whey protein mixed in a drink every visit for 4 weeks |
| Whey | Active comparator | Dietary Supplement: Whey proteinSubjects received 25g whey protein in a drink every visit for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects received 25g maltodextrin in a drink every visit for 4 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • At least one-year of resistance training experience
Key exclusion criteria (4 listed)
- • Inability to perform physical exercise (determined by health and activity questionnaire)
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 |
|---|---|---|
| ProHydrolase®Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink | Dietary supplement | Whey + ProHydrolase® |
| Whey proteinSubjects received 25g of whey protein powder mixed to together in a drink | Dietary supplement | Whey |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Amino acid absorption
Time frame: 4 weeks
To examine the amino acid absorption following acute resistance exercise between three supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3) Non-Caloric Placebo (PL)
mTORC1 pathway
Time frame: 4 weeks
To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway
Endocrine markers
Time frame: 4 weeks
To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.
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 30 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProHydrolase® and Whey protein in people with Amino Acids, run by Deerland Enzymes at 1 site in United States.
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 4 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 30 Oct 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Amino acid absorption (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 30 Oct 2019.