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Active, Not Recruiting

NCT Number: NCT06158204

Improving Metabolic & Mental Health in Female Healthcare Shift Workers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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 to be mixed with water 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"

Primary outcomes

  1. Visceral fat percentage

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Change in visceral fat as a percentage of total fat mass as measured by dual x-ray absorptiometry. Lower values are optimal.

  2. Mental Quality of Life

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Research ANd Development (RAND) Short Form-12 will assess mental quality of life (Range 0-100; 100 is optimal).

  3. Physical Quality of Life

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Research ANd Development (RAND) Short Form-12 will assess physical quality of life (Range 0-100; 100 is optimal).

Secondary outcomes

  1. Fasting serum triglycerides

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Phlebotomy will be obtained while fasted 8+ hours and triglycerides will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.

  2. Fasting alanine aminotransferase (ALT)

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Phlebotomy will be obtained while fasted 8+ hours and alanine aminotransferase (ALT) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.

  3. Fasting serum blood glucose

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Phlebotomy will be obtained while fasted 8+ hours and blood glucose will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.

  4. Fasting serum low-density lipoproteins (LDL)

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Phlebotomy will be obtained while fasted 8+ hours and low-density lipoproteins (LDL) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal.

  5. Sleep - accelerometry

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Average minutes of total daily sleep.

  6. Total caloric intake

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Four 24-hour dietary recalls will be obtained every four weeks and entered into the and analyzed in the Nutrition Data System for Research (NDSR).

  7. Total protein intake

    Time frame: Change from 0-8 weeks; 8-16 weeks

    Four 24-hour dietary recalls will be obtained every four weeks and entered into the and analyzed in the Nutrition Data System for Research (NDSR).

  8. Stool microbiome composition

    Time frame: Change from 0-8 weeks; 8-16 weeks

    16S changes in microbiome alpha diversity.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 6, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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