- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491188
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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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