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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.
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intervention | Experimental | Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only |
|
| Delayed intervention | Active Comparator | Participants will receive the 8-week intervention after 8 weeks of observation-only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral fat percentage | Change in visceral fat as a percentage of total fat mass as measured by dual x-ray absorptiometry. Lower values are optimal. | Change from 0-8 weeks; 8-16 weeks |
| Mental Quality of Life | Research ANd Development (RAND) Short Form-12 will assess mental quality of life (Range 0-100; 100 is optimal). | Change from 0-8 weeks; 8-16 weeks |
| Physical Quality of Life | Research ANd Development (RAND) Short Form-12 will assess physical quality of life (Range 0-100; 100 is optimal). | Change from 0-8 weeks; 8-16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting serum triglycerides | 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. | Change from 0-8 weeks; 8-16 weeks |
| Fasting alanine aminotransferase (ALT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Frugé, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36849 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41228416 | Derived | Robinson LA, Lennon S, Pegel AR, Strickland KP, Feeley CA, Watts SO, J Van Der Pol W, Roberts MD, Greene MW, Fruge AD. A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic and Mental Health in Female Healthcare Night-Shift Workers. Nutrients. 2025 Oct 24;17(21):3342. doi: 10.3390/nu17213342. |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D050177 | Overweight |
| D009765 | Obesity |
| D000073397 | Occupational Stress |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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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. |
| Change from 0-8 weeks; 8-16 weeks |
| Fasting serum blood glucose | 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. | Change from 0-8 weeks; 8-16 weeks |
| Fasting serum low-density lipoproteins (LDL) | 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. | Change from 0-8 weeks; 8-16 weeks |
| Sleep - accelerometry | Average minutes of total daily sleep. | Change from 0-8 weeks; 8-16 weeks |
| Total caloric intake | 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). | Change from 0-8 weeks; 8-16 weeks |
| Total protein intake | 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). | Change from 0-8 weeks; 8-16 weeks |
| Stool microbiome composition | 16S changes in microbiome alpha diversity. | Change from 0-8 weeks; 8-16 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |