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Probiotics in Occupational Shift Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951689
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : September 19, 2018
Sponsor:
Collaborators:
National Strength and Conditioning Association Foundation
Winclove Probiotics
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE November 1, 2016
Last Update Posted Date September 19, 2018
Study Start Date  ICMJE September 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
Visceral Fat [ Time Frame: 6 weeks ]
measured by ultrasound
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2016)
  • Ratio of fat in the abdominal region vs. hip region [ Time Frame: 6 weeks ]
    Measured from dual energy x-ray absorptiometry
  • Body Fat [ Time Frame: 6 weeks ]
    measured from dual energy x-ray absorptiometry
  • Lean body mass [ Time Frame: 6 weeks ]
    measured from dual energy x-ray absorptiometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics in Occupational Shift Workers
Official Title  ICMJE Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Shift-Work Related Sleep Disturbance
  • Healthy
Intervention  ICMJE
  • Dietary Supplement: Probiotic
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Probiotic
    Multi-strain probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo
    Maltodextrin placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2018)
45
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2016)
60
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 22 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02951689
Other Study ID Numbers  ICMJE 16-1397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Strength and Conditioning Association Foundation
  • Winclove Probiotics
Investigators  ICMJE
Study Director: Abbie Smith-Ryan, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP