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Clinical Trials/NCT05153759
NCT05153759RecruitingNot Applicable

EMS Providers' Health Initiative Study

State University of New York at Buffalo1 site in 1 country40 target enrollmentStarted: June 7, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Compliance

Study Overview

Brief Summary

This study aims to explore dietary factors that influence glycemic control in night shift EMS providers and to test the feasibility of a dietary intervention among these providers.

Detailed Description

This study can be broken down into two phases. Both phases will take place over the course of 3 weeks. During the first week, participants will be scheduled for a single 60-90 minute zoom appointment. During this appointment, informed consent will be obtained, participants will provide health and demographic information, complete several questionnaires, and be familiarized with study protocols. The following week, participants will wear a continuous glucose monitor, actigraph activity monitor, document everything they have to eat and drink, and rate their daily stress levels. Participants will continue this during the final week and will be randomized to consume either a 2:1 or 1:1 protein to carbohydrate ratio during the night shift during this week.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Emergency medical service (EMS) provider
  • Works night shift only for at least one year
  • Provides patient care as primary duty

Exclusion Criteria

  • Diagnosis of a metabolic disease (i.e. diabetes, prediabetes, metabolic syndrome)
  • Taking medication to lower blood glucose
  • Pregnant or planning to become pregnant
  • Diagnosis of kidney disease or impairment
  • Allergies or intolerances to study foods
  • Digestive disorder

Arms & Interventions

High protein

Active Comparator

Consuming a meal composed of 2:1 grams of protein to carbohydrate during the night shift between 7pm-7am

Intervention: Meal service (Other)

Moderate protein

Placebo Comparator

Consuming a meal composed of 1:1 grams of protein to carbohydrate during the night shift between 7pm-7am

Intervention: Meal service (Other)

Outcomes

Primary Outcomes

Compliance

Time Frame: Four days

Percent of participants who adhere to the dietary intervention

Glycemic control

Time Frame: Two weeks

Daily mean blood glucose

Secondary Outcomes

  • Perceived stress(Two weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tegan Mansouri

Postdoctoral Associate

State University of New York at Buffalo

Study Sites (1)

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