Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation

July 28, 2020 updated by: Jeremy Townsend, Lipscomb University

Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women

Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.

Study Overview

Study Type

Interventional

Enrollment (Actual)

22

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

    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Jeremy Townsend

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 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-34 years old Participants must have at least 1 year of resistance training experience.
  • Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
  • Are free of musculoskeletal injuries
  • Are not taking medications that may interfere with study measurements

Exclusion Criteria:

  • Taking any other nutritional supplement or performance enhancing drug.
  • Any chronic illness that causes continuous medical care
  • Taking any other nutritional supplement or performance enhancing drug.
  • 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days
1 x10-9 CFU Bacillus subtilis DE111 probiotic
Placebo Comparator: Placebo
Maltodextrin placebo was consumed for 28-days
Maltodextrin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Amino Acid response
Time Frame: 28-days
We measured plasma amino acid concentrations before and after the 28-day intervention
28-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: 28-days
Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis.
28-days

Collaborators and Investigators

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

Collaborators

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)

January 8, 2018

Primary Completion (Actual)

May 3, 2018

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 01082018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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