Probiotics in Occupational Shift Workers

Not Applicable

Completed

• Conditions: Healthy; Shift-Work Related Sleep Disturbance
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT02951689
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-30
• Study First Posted: 2016-11-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Multi-strain probiotic
Placebo	Placebo	Maltodextrin placebo

Primary Outcome Measures

Name	Time	Method
Visceral Fat	6 weeks	measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
Body Fat	6 weeks	measured from dual energy x-ray absorptiometry
Ratio of fat in the abdominal region vs. hip region	6 weeks	Measured from dual energy x-ray absorptiometry
Lean body mass	6 weeks	measured from dual energy x-ray absorptiometry

Trial Locations

Locations (1)

Applied Physiology Laboratory; 🇺🇸 Chapel Hill, North Carolina, United States