Probiotics in Occupational Shift Workers | NCT02951689

Studies
Probiotics in Occupational Shift Workers

NCT02951689

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Sep 19, 2018Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Shift-Work Related Sleep Disturbance
Healthy

Interventions

Probiotic
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Oct 27, 2016

First Submission Date that Met QC Criteria

Oct 30, 2016

First Posted Date

Nov 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2018

Last Update Posted Date

Sep 19, 2018Actual

Name	Class
National Strength and Conditioning Association	OTHER
Winclove Probiotics B.V.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	Multi-strain probiotic	Dietary Supplement: Probiotic
Placebo	Placebo Comparator	Maltodextrin placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement		Probiotic
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visceral Fat	measured by ultrasound	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Ratio of fat in the abdominal region vs. hip region	Measured from dual energy x-ray absorptiometry	6 weeks
Body Fat	measured from dual energy x-ray absorptiometry

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena