Probiotics in Occupational Shift Workers

NCT02951689 | Completed

• 1 other identifier: 16-1397
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visceral Fat

  measured by ultrasound

  6 weeks

Secondary Outcomes (3)

• Ratio of fat in the abdominal region vs. hip region

  6 weeks

• Body Fat

  6 weeks

• Lean body mass

  6 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Multi-strain probiotic

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Maltodextrin placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Strength and Conditioning Association: collaborator
• Winclove Probiotics B.V.: collaborator

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)