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

• Sponsor: Lipscomb University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04491188
• Collaborator: Deerland Enzymes (Industry)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Focus of Study is Amino Acid Appearace in Blood	Dietary Supplement: Bacillus subtilis DE111; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women
• Actual Study Start Date: Jan 8, 2018
• Actual Primary Completion Date: May 3, 2018
• Actual Study Completion Date: May 3, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma Amino Acid response [28-days]

   We measured plasma amino acid concentrations before and after the 28-day intervention

Secondary Outcome Measures

1. Body Composition [28-days]

   Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeremy Townsend	Nashville	Tennessee	United States	37215

Sponsors and Collaborators

• Lipscomb University
• Deerland Enzymes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeremy Townsend, Assistant Professor, Lipscomb University
• ClinicalTrials.gov Identifier: NCT04491188
• Other Study ID Numbers: 01082018
• First Posted: Jul 29, 2020
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 29, 2020