Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144114
Recruitment Status : Completed
First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Lipscomb University
Information provided by (Responsible Party):
Deerland Enzymes

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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). 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.

Condition or disease Intervention/treatment Phase
Amino Acids Dietary Supplement: ProHydrolase® Dietary Supplement: Whey protein Dietary Supplement: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Whey + ProHydrolase®
Subjects received 250mg of ProHydrolase® along with 25g of whey protein mixed in a drink every visit for 4 weeks
 Dietary Supplement: ProHydrolase®
Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink
Active Comparator: Whey
Subjects received 25g whey protein in a drink every visit for 4 weeks
 Dietary Supplement: Whey protein
Subjects received 25g of whey protein powder mixed to together in a drink
Placebo Comparator: Placebo
Subjects received 25g maltodextrin in a drink every visit for 4 weeks
 Dietary Supplement: Placebo
Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144114


Locations
Layout table for location information
United States, Tennessee
Lipscomb University
Nashville, Tennessee, United States, 37204
Sponsors and Collaborators
Deerland Enzymes
Lipscomb University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Deerland Enzymes
ClinicalTrials.gov Identifier: NCT04144114    
Other Study ID Numbers: Pro18
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deerland Enzymes:
Amino Acids
Intramuscular Anabolic Signaling
Endocrine Response
Resistance Training