Probiotics in Occupational Shift Workers

Completed · Not applicable · Has a placebo group

Conditions studied: Shift-Work Related Sleep Disturbance, Healthy

In brief

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.

Key facts

Study ID

NCT02951689

Run by

University of North Carolina, Chapel Hill

People needed

45

Starts

2016-09-01

Expected to finish

2018-01-01

Last updated by the study team

2018-09-19

Who can join

Age: 22 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Applied Physiology Laboratory — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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