Probiotics in Occupational Shift Workers

NCT ID: NCT02951689

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-01-31

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.

Conditions

Shift-Work Related Sleep Disturbance; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Probiotic

Multi-strain probiotic

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Strength and Conditioning Association

OTHER

Sponsor Role: collaborator

Winclove Probiotics B.V.

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbie Smith-Ryan, PhD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

Applied Physiology Laboratory

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

16-1397

Identifier Type: -

Identifier Source: org_study_id