Probiotics in Occupational Shift Workers
Primary Purpose
Shift-Work Related Sleep Disturbance, Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional other trial for Shift-Work Related Sleep Disturbance
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)
Sites / Locations
- Applied Physiology Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Multi-strain probiotic
Maltodextrin placebo
Outcomes
Primary Outcome Measures
Visceral Fat
measured by ultrasound
Secondary Outcome Measures
Ratio of fat in the abdominal region vs. hip region
Measured from dual energy x-ray absorptiometry
Body Fat
measured from dual energy x-ray absorptiometry
Lean body mass
measured from dual energy x-ray absorptiometry
Full Information
NCT ID
NCT02951689
First Posted
October 27, 2016
Last Updated
September 17, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Strength and Conditioning Association Foundation, Winclove Probiotics B.V.
1. Study Identification
Unique Protocol Identification Number
NCT02951689
Brief Title
Probiotics in Occupational Shift Workers
Official Title
Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Strength and Conditioning Association Foundation, Winclove Probiotics B.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Related Sleep Disturbance, Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Multi-strain probiotic
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Visceral Fat
Description
measured by ultrasound
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Ratio of fat in the abdominal region vs. hip region
Description
Measured from dual energy x-ray absorptiometry
Time Frame
6 weeks
Title
Body Fat
Description
measured from dual energy x-ray absorptiometry
Time Frame
6 weeks
Title
Lean body mass
Description
measured from dual energy x-ray absorptiometry
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Smith-Ryan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
Applied Physiology Laboratory
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Probiotics in Occupational Shift Workers
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