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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

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.


Condition or disease Intervention/treatment Phase
Shift-Work Related Sleep Disturbance Healthy Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
Study Start Date : September 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: Probiotic
Multi-strain probiotic
Dietary Supplement: Probiotic
Placebo Comparator: Placebo
Maltodextrin placebo
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Visceral Fat [ Time Frame: 6 weeks ]
    measured by ultrasound


Secondary Outcome Measures :
  1. Ratio of fat in the abdominal region vs. hip region [ Time Frame: 6 weeks ]
    Measured from dual energy x-ray absorptiometry

  2. Body Fat [ Time Frame: 6 weeks ]
    measured from dual energy x-ray absorptiometry

  3. Lean body mass [ Time Frame: 6 weeks ]
    measured from dual energy x-ray absorptiometry



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951689


Locations
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United States, North Carolina
Applied Physiology Laboratory
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Strength and Conditioning Association Foundation
Winclove Probiotics
Investigators
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Study Director: Abbie Smith-Ryan, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02951689    
Other Study ID Numbers: 16-1397
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms