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

October 29, 2019 updated by: Deerland Enzymes
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • 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

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Lipscomb University

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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks
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
4 weeks
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.
4 weeks

Collaborators and Investigators

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

Sponsor

Deerland Enzymes

Collaborators

Lipscomb University

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)

August 1, 2018

Primary Completion (Actual)

December 7, 2018

Study Completion (Actual)

December 7, 2018

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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