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OpenTrials
Completed

NCT Number: NCT02951689

Probiotics in Occupational Shift Workers

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.

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Key information

Conditions

Shift-Work Related Sleep Disturbance Healthy

Age range

22 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Visceral Fat

    Time frame: 6 weeks

    measured by ultrasound

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Strength and Conditioning Association
  • Winclove Probiotics B.V.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2016
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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