Probiotics in Occupational Shift Workers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 22 - 55 |
| Updated: | 9/21/2018 |
| Start Date: | September 2016 |
| End Date: | January 2018 |
Influence of Probiotics on Body Composition and Health 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.
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.
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)
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