NCT04144114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 28, 2019

Last Update Submit

October 29, 2019

Conditions

Keywords

Amino AcidsIntramuscular Anabolic SignalingEndocrine ResponseResistance Training

Outcome Measures

Primary Outcomes (3)

  • 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)

    4 weeks

  • mTORC1 pathway

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

    4 weeks

  • Endocrine markers

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

    4 weeks

Study Arms (3)

Whey + ProHydrolase®

EXPERIMENTAL

Subjects received 250mg of ProHydrolase® along with 25g of whey protein mixed in a drink every visit for 4 weeks

Dietary Supplement: ProHydrolase®

Whey

ACTIVE COMPARATOR

Subjects received 25g whey protein in a drink every visit for 4 weeks

Dietary Supplement: Whey protein

Placebo

PLACEBO COMPARATOR

Subjects received 25g maltodextrin in a drink every visit for 4 weeks

Dietary Supplement: Placebo

Interventions

ProHydrolase®DIETARY_SUPPLEMENT

Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink

Whey + ProHydrolase®
Whey proteinDIETARY_SUPPLEMENT

Subjects received 25g of whey protein powder mixed to together in a drink

Whey
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lipscomb University

Nashville, Tennessee, 37204, United States

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

August 1, 2018

Primary Completion

December 7, 2018

Study Completion

December 7, 2018

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations