Shift-Work Related Sleep DisturbanceNCT02951689
Probiotics in Occupational Shift Workers
A study testing Probiotic in people with Shift-Work Related Sleep Disturbance and Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Related Sleep Disturbance, Healthy
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Shift-Work Related Sleep Disturbance, Healthy
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Multi-strain probiotic Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Maltodextrin placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral Fat
measured by ultrasound
Measured: 6 weeks
Secondary outcomes (3)
Ratio of fat in the abdominal region vs. hip region
Measured from dual energy x-ray absorptiometry
Measured: 6 weeks
Body Fat
measured from dual energy x-ray absorptiometry
Measured: 6 weeks
Lean body mass
measured from dual energy x-ray absorptiometry
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Related Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Strength and Conditioning Association, Winclove Probiotics B.V.
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951689
- Sponsor's protocol ID
- 16-1397
- Status last verified
- Sep 2018
- First submitted
- 27 Oct 2016
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Probiotics on Body Composition and Health in Occupational Shift Workers
- ClinicalTrials.gov ID
- NCT02951689
- Acronym / sponsor ID
- 16-1397
- Conditions
- Shift-Work Related Sleep Disturbance, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Strength and Conditioning Association, Winclove Probiotics B.V.
- Study start
- Sep 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticMulti-strain probiotic |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin placebo |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic | Dietary supplement | Probiotic |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Visceral Fat
Time frame: 6 weeks
measured by ultrasound
3 secondary outcomes
Ratio of fat in the abdominal region vs. hip region
Time frame: 6 weeks
Body Fat
Time frame: 6 weeks
Lean body mass
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbie Smith-Ryan, PhD study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Shift-Work Related Sleep Disturbance and Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral Fat (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.