NCT05153759

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jun 2022Dec 2026

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

November 29, 2021

Last Update Submit

January 23, 2026

Conditions

Keywords

EMSNight shiftNutritionInsulin resistanceCircadian rhythm

Outcome Measures

Primary Outcomes (2)

  • Glycemic control

    Daily mean blood glucose

    Two weeks

  • Compliance

    Percent of participants who adhere to the dietary intervention

    Four days

Secondary Outcomes (1)

  • Perceived stress

    Two weeks

Study Arms (2)

High protein

ACTIVE COMPARATOR

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

Other: Meal service

Moderate protein

PLACEBO COMPARATOR

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

Other: Meal service

Interventions

The primary goal is to pilot the feasibility of a meal service intervention in night shift workers

High proteinModerate protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Hostler, PhD

    University at Buffalo

    STUDY CHAIR

Central Study Contacts

Tegan H Mansouri, PhD

CONTACT

Jocelyn Stooks, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Associate

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

June 7, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

IPD will be de-identified and kept in a password protected database (REDcap.com)

Locations