Clinical trial NCT02951689: Probiotics in Occupational Shift Workers
Official title: Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Related Sleep Disturbance
Healthy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Strength and Conditioning Association
name: Winclove Probiotics B.V.
First posted: 2016-11-01
Enrollment: 45
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Visceral Fat
timeFrame: 6 weeks
Secondary outcomes:
measure: Ratio of fat in the abdominal region vs. hip region
timeFrame: 6 weeks
measure: Body Fat
timeFrame: 6 weeks
measure: Lean body mass
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: STUDY_DIRECTOR
References: