Clinical Trials Directory

Trials / Completed

CompletedNCT02951689

Probiotics in Occupational Shift Workers

Influence of Probiotics on Body Composition and Health in Occupational Shift Workers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
Female
Age
22 Years – 55 Years
Healthy volunteers
Accepted

Summary

Purpose: To evaluate the influence of probiotic supplementation on body composition and other markers of health in occupational shift-workers. Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a shift-working schedule. Procedures (methods): In a randomized, placebo-controlled intervention, subjects will complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as well as a 6-week intervention period. Prescreening will include written informed consent, a health history questionnaire, baseline anthropometric measures, assessment of resting heart rate, and exercise protocol familiarization. Baseline testing will involve body composition, a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of supplementation that includes 2 electronic contacts, followed by post-testing that will occur in the same fashion as baseline testing.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbiotic
DIETARY_SUPPLEMENTPlacebo

Timeline

Start date
2016-09-01
Primary completion
2018-01-01
Completion
2018-01-01
First posted
2016-11-01
Last updated
2018-09-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02951689. Inclusion in this directory is not an endorsement.