NCT04491188

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 20, 2020

Last Update Submit

July 28, 2020

Conditions

Focus of Study is Amino Acid Appearace in Blood

Outcome Measures

Primary Outcomes (1)

  • Plasma Amino Acid response

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

    28-days

Secondary Outcomes (1)

  • Body Composition

    28-days

Study Arms (2)

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

Bacillus subtilis DE111DIETARY_SUPPLEMENT

1 x10-9 CFU Bacillus subtilis DE111 probiotic

Probiotic
PlaceboDIETARY_SUPPLEMENT

Maltodextrin placebo

Placebo

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeremy Townsend

Nashville, Tennessee, 37215, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 29, 2020

Study Start

January 8, 2018

Primary Completion

May 3, 2018

Study Completion

May 3, 2018

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

US(1)