Probiotics in Occupational Shift Workers

University of North Carolina (UNC)

Status

Completed

Conditions

Healthy

Shift-Work Related Sleep Disturbance

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02951689

16-1397

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

Female

Ages

22 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)