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Clinical Trials/NCT04182867
NCT04182867
Terminated
Not Applicable

Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work: Shift-eat (Night) Pilot Study

King's College London1 site in 1 country4 target enrollmentMay 28, 2021
ConditionsShift Work

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shift Work
Sponsor
King's College London
Enrollment
4
Locations
1
Primary Endpoint
Blood glucose variability (mean amplitude of glycaemic excursions)
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

The aim of this pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees.

Detailed Description

An increasing body of data reports deterioration of cardio-metabolic health in shift workers. For example, large scale meta-analyses have reported shift workers to be at increased risk of developing type 2 diabetes and of experiencing a coronary event, compared to day working employees. Shift work causes complex changes in physiology (desynchrony of circadian rhythms) and behaviors including activity, sleep and eating patterns. The importance of meal timing is becoming increasingly recognized in both chronobiology and nutrition fields, with emerging awareness of 'chrono-nutrition', the interaction between nutrition and circadian time. Given the importance to the economy of a healthy aging workforce, and the increase in shift work prevalence, it is important to establish if diet modification can reduce the health disparities between shift and day working employees.

Registry
clinicaltrials.gov
Start Date
May 28, 2021
End Date
October 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.
  • Body mass index between 18.5 and 35 kg/m
  • Weight stable (no weight change by more than 3 kg in the last 2 months).
  • Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.
  • Not pregnant or breastfeeding.
  • Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
  • Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas).
  • Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
  • Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers)
  • Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood glucose variability (mean amplitude of glycaemic excursions)

Time Frame: 3 night shifts, an average of 72 hours

24-hr blood glucose variability measured by continuous glucose monitor

Blood glucose variability (time in range)

Time Frame: 3 night shifts, an average of 72 hours

24-hr blood glucose variability measured by continuous glucose monitor

Heart rate variability

Time Frame: 3 night shifts, an average of 72 hours

24-hr heart rate variability measured by heart rate monitor

Blood glucose variability (coefficient variation)

Time Frame: 3 night shifts, an average of 72 hours

24-hr blood glucose variability measured by continuous glucose monitor

Secondary Outcomes

  • Acceptability of test diet(3 night shifts, an average of 72 hours)

Study Sites (1)

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