Probiotics in Occupational Shift Workers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951689
• Other study ID #: 16-1397
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyssomnias
• Healthy
• Parasomnias
• Shift-Work Related Sleep Disturbance
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Probiotic

• Placebo

Locations

Country	Name	City	State
United States	Applied Physiology Laboratory	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Strength and Conditioning Association Foundation, Winclove Probiotics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral Fat	measured by ultrasound	6 weeks
Secondary	Ratio of fat in the abdominal region vs. hip region	Measured from dual energy x-ray absorptiometry	6 weeks
Secondary	Body Fat	measured from dual energy x-ray absorptiometry	6 weeks
Secondary	Lean body mass	measured from dual energy x-ray absorptiometry	6 weeks