Probiotics in Occupational Shift Workers

Study Overview
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Brief Summary
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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.

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

Conditions
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Shift-Work Related Sleep Disturbance, Healthy

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, pre-menopausal women Currently employed on a shift-working (rotating, evening, or night) schedule and has maintained this schedule ≥ 6 months prior to enrollment Participant agrees to maintain usual activity lifestyle Participant has a body mass index of ≥25 kg/m2 Participant has provided written and dated informed consent to participate in the study Participant is willing and able to comply with the protocol Participant is apparently healthy and free from disease, as determined by a health history questionnaire Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days Participant is not currently pregnant and does not desire to become pregnant in the next 8 weeks. Exclusion Criteria: Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders Participant is using, or has used a probiotic supplements within 8 weeks prior to enrollment Participant has lost or gained greater than 8 pounds within the previous 2 months Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment Participant had or currently has a self-identified eating disorder Participant is pregnant or plans on becoming pregnant Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Multi-strain probiotic | Dietary Supplement: Probiotic<br> <br> |
| Placebo Comparator: Placebo<br>Maltodextrin placebo | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral Fat | measured by ultrasound | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of fat in the abdominal region vs. hip region | Measured from dual energy x-ray absorptiometry | 6 weeks | 
| Body Fat | measured from dual energy x-ray absorptiometry | 6 weeks | 
| Lean body mass | measured from dual energy x-ray absorptiometry | 6 weeks |