Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColorado State University

About this trial

People who experience repeated bouts of circadian misalignment, such as shift workers, are at higher risk of cardiovascular disease (CVD) and Type 2 diabetes (T2D) compared to daytime workers. However, the mechanism(s) by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown. This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function, insulin sensitivity, glucose homeostasis and muscle lipid accumulation, which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment, which includes more than 20% of the US workforce.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-65 years old

worked the night shift for the last 1 year or more,

habitually sleep 5-9 hours per 24h period (night shift workers typically experience chronic insufficient sleep),

body mass index (BMI) of 20.0 - 35.0 kg/m2 and weight stable (plus or minus 5% of current body weight in the last 6 months); sedentary to mild physical activity level (less than 2 days of planned exercise per week);

Disqualifiers

existing diagnosed sleep or eating disorder (e.g. obstructive sleep apnea [OSA], periodic limb movements of sleep [PLMS], narcolepsy, travel more than 1 time zone in 3 weeks before the study; anorexia nervosa, more than one food allergy to maintain flexibility in diet planning);

following any TRE (time-restricted eating) or intermittent fasting plan in the last year;

following any special diet plan, like paleo, keto, gluten-free or vegan, that can affect the primary lipid outcome measures in the last 6 months; any clinically significant surgical condition within the last year;

diagnosed diabetes or cardiovascular disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Time-restricted eating

    Behavioral

    Night shift workers will participate in 4 weeks of fasting during the biological nighttime while remaining awake during overnight work shifts.

  • Control eating

    Behavioral

    Night shift workers will participate in 4 weeks of Control eating across the daytime and nighttime hours while remaining awake during overnight work shifts.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control eating during overnight work shiftExperimental treatment 1 intervention
Group B: Time-restricted eating during overnight work shiftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure via 24-hour assessments

Four weeks of TRE during shift work will reduce 24-hour blood pressure versus Control.

Time frame
Collected during inpatient laboratory visit after 4 weeks of Control and TRE
2

Insulin sensitivity via clamp

Four weeks of TRE during shift work will improve insulin sensitivity versus Control.

Time frame
Collected during inpatient laboratory visit after 4 weeks of Control and TRE

Secondary outcomes

1

Cerebrovascular reactivity via transcranial doppler

Four weeks of TRE during shift work will improve cerebrovascular reactvity versus Control.

Time frame
Collected during inpatient laboratory visit after 4 weeks of Control and TRE
2

Muscle lipid accumulation via lipidomics

Four weeks of TRE during shift work will reduce muscle lipid accumulation versus Control.

Time frame
Collected during inpatient laboratory visit after 4 weeks of Control and TRE

Other outcomes

1

24-hour blood sampling for lipids, glucose, insulin, and vascular markers

Four weeks of TRE during shift work will improve 24-hour markers of vascular function versus Control.

Time frame
Collected during inpatient laboratory visit after 4 weeks of Control and TRE

Sponsors and contacts

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Colorado State University

Lead sponsor

University of Colorado, Denver

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator