Clinical trial NCT06158204: Improving Metabolic & Mental Health in Female Healthcare Shift Workers
Official title: A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep, Inadequate
Overweight and Obesity
Work Related Stress
Healthy Lifestyle
Keywords: circadian rhythm
protein
shift work
female
sleep
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Circadian rhythm disruption caused by shift work alters metabolic and hormonal pathways, which accelerates chronic disease onset, leading to decreased quality and quantity of life. Preclinical studies indicate that optimizing nutrient and sleep/rest timing can mitigate these effects.

Female nightshift healthcare workers will be recruited to participate in a randomized crossover trial in which participants will be expected to follow the prescribed lifestyle intervention for eight weeks during the first or second eight-week periods of the study.

Detailed description: Clinical assessments will include DEXA, phlebotomy, questionnaires, and stool collection, which will be completed at weeks 0, 8, and 16 to assess changes in metabolic health and quality of life. Four days of 24-hour dietary recalls will be collected at baseline, and weeks 4, 8, 12, and 16. Garmin Vivofit4 activity trackers will be provided to all participants at baseline, and participants will be reminded to sync the devices once weekly at minimum.

During the 8-week intervention phase, participants will receive guidance on when and what to eat and when to sleep and be physically active. Additionally, participants will be provided with whey protein isolate powder and grain-based snack bars to be consumed primarily during work shifts. Lean body mass (kg) will be used to prescribe total caloric (\~30kcal/kg lean mass) and protein (2g/kg lean mass) needs and sleep/rest goals will be 6-8 hours per 24 hour "day."

Eligibility criteria: Inclusion Criteria:

* Female
* 18-50 years old
* BMI between 27 and 40 kg/m2
* \>6 months in current predominantly night shift (average 30+ hours/week) schedule
* Can read and speak English
* Willing to correspond with study staff using smartphone technologies

Exclusion Criteria:

* Pregnant or undergoing hormonal treatment for fertility
* Major changes in any prescription medications within 3 months
* Major surgeries in last 3 months
* Diagnosis of Type 2 Diabetes or other major endocrine diseases
* Diagnosed food allergies or significant dietary limitations
* Currently engaged in intensive weight loss program
* Minimal medically necessary radiation exposure within the last year

Primary outcomes:
measure: Visceral fat percentage
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Mental Quality of Life
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Physical Quality of Life
timeFrame: Change from 0-8 weeks; 8-16 weeks
Secondary outcomes:
measure: Fasting serum triglycerides
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Fasting alanine aminotransferase (ALT)
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Fasting serum blood glucose
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Fasting serum low-density lipoproteins (LDL)
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Sleep - accelerometry
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Total caloric intake
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Total protein intake
timeFrame: Change from 0-8 weeks; 8-16 weeks
measure: Stool microbiome composition
timeFrame: Change from 0-8 weeks; 8-16 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Andrew D Frugé, PhD
role: PRINCIPAL_INVESTIGATOR
References: