Plasma Amino Acid Response to Whey Protein Ingestion Foll... | NCT04491188

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

NCT04491188

Sponsor

Lipscomb University

Status

Completed

Last Update Posted

Jul 29, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Focus of Study is Amino Acid Appearace in Blood

Interventions

Bacillus subtilis DE111
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2018Actual

Primary Completion Date

May 3, 2018Actual

Completion Date

May 3, 2018Actual

First Submitted Date

Jul 20, 2020

First Submission Date that Met QC Criteria

Jul 28, 2020

First Posted Date

Jul 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2020

Last Update Posted Date

Jul 29, 2020Actual

Name	Class
Deerland Enzymes	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days	Dietary Supplement: Bacillus subtilis DE111
Placebo	Placebo Comparator	Maltodextrin placebo was consumed for 28-days	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bacillus subtilis DE111	Dietary Supplement	1 x10-9 CFU Bacillus subtilis DE111 probiotic	Probiotic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

34 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeremy Townsend		Nashville	Tennessee	37215	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided