Probiotics in Occupational Shift Workers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Shift-Work Related Sleep Disturbance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin placebo	Dietary supplement: Placebo
Experimental: Probiotic; Multi-strain probiotic	Dietary supplement: Probiotic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Winclove Probiotics B.V.; National Strength and Conditioning Association Foundation
• Investigators: Study Director: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 30, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 16-1397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO