Auburn University
Auburn, Alabama, 36849, United States
NCT Number: NCT06158204
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.
This study is active but is not currently recruiting participants.
18 year–50 year
Female
Interventional
Not applicable
Auburn, Alabama, 36849, United States
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."
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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"
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.
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).
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).
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.
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.
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.
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.
Time frame: Change from 0-8 weeks; 8-16 weeks
Average minutes of total daily sleep.
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).
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).
Time frame: Change from 0-8 weeks; 8-16 weeks
16S changes in microbiome alpha diversity.
Auburn University
Other
A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers
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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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