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

• Sponsor: Deerland Enzymes (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04144114
• Collaborator: Lipscomb University (Other)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2018
• Actual Primary Completion Date: Dec 7, 2018
• Actual Study Completion Date: Dec 7, 2018

Arms and Interventions

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

Primary Outcome Measures

1. Amino acid absorption [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 [4 weeks]

   To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on the mTORC1 complex pathway

3. Endocrine markers [4 weeks]

   To examine three supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on circulating concentrations of endocrine biomarkers.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Lipscomb University	Nashville	Tennessee	United States	37204

Sponsors and Collaborators

• Deerland Enzymes
• Lipscomb University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deerland Enzymes
• ClinicalTrials.gov Identifier: NCT04144114
• Other Study ID Numbers: Pro18
• First Posted: Oct 30, 2019
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Oct 30, 2019