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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | |
| DIETARY_SUPPLEMENT | Placebo |
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.