Probiotics in Occupational Shift Workers
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|ClinicalTrials.gov Identifier: NCT02951689|
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : September 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Shift-Work Related Sleep Disturbance Healthy||Dietary Supplement: Probiotic Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Influence of Probiotics on Body Composition and Health in Occupational Shift Workers|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Dietary Supplement: Probiotic
Placebo Comparator: Placebo
Dietary Supplement: Placebo
- Visceral Fat [ Time Frame: 6 weeks ]measured by ultrasound
- Ratio of fat in the abdominal region vs. hip region [ Time Frame: 6 weeks ]Measured from dual energy x-ray absorptiometry
- Body Fat [ Time Frame: 6 weeks ]measured from dual energy x-ray absorptiometry
- Lean body mass [ Time Frame: 6 weeks ]measured from dual energy x-ray absorptiometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951689
|United States, North Carolina|
|Applied Physiology Laboratory|
|Chapel Hill, North Carolina, United States, 27599|
|Study Director:||Abbie Smith-Ryan, PhD||University of North Carolina, Chapel Hill|