Strategies to improve metabolic health for night shift workers
Time-restricted Feeding to Mitigate Metabolic Impairments During Circadian Misalignment
NA · Colorado State University · NCT04966351
This study tests if not eating during the night can help night shift workers improve their metabolic health and reduce their risk of obesity and diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Colorado State University (other) |
| Locations | 1 site (Fort Collins, Colorado) |
| Trial ID | NCT04966351 on ClinicalTrials.gov |
What this trial studies
This project investigates whether avoiding food intake during the biological night can help mitigate the negative effects of circadian misalignment on metabolic health in adults who work night shifts. The study focuses on individuals who are at risk for obesity and diabetes due to their work schedules, examining the impact of time-restricted feeding during the daytime. By identifying effective behavioral countermeasures, the research aims to provide solutions for a significant portion of the workforce affected by nonstandard hours. The study will include participants aged 18-35 with normal weight and specific sleep and activity histories.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-35 with a normal BMI and specific sleep and activity patterns.
Not a fit: Patients with significant medical, psychiatric, or sleep disorders, or those who have worked shifts recently, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of metabolic diseases in individuals working nonstandard hours.
How similar studies have performed: While there have been limited attempts to address metabolic impairments due to circadian misalignment, this approach is relatively novel and untested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 18-35 old; men and women; equal numbers of women and men will be included.
2. Body Mass Index (BMI) between 20.0 and 24.9 ("normal" weight).
3. Physical activity history: inactive to habitual moderate physical activity level
4. Sleep/wake history: habitual sleep duration between 7-9.25 hours.
5. Altitude history: Potential subjects must have lived at Denver altitude or higher for at least 3 months prior to inpatient stay.
Exclusion Criteria:
1. Any clinically significant medical, psychiatric, or sleep disorder
2. Use of prescribed medications/supplements/illicit drugs within one month prior to study
3. History of shift work in year prior to study, or travel more than one time zone in three weeks prior to study. \[NOTE: Subjects can be studied at a later date.\]
4. Women with history of prior gynecological pathology, \<1 year post-partum, breast-feeding and/or pregnant.
5. Non-English speakers will be excluded, as we do not have access to a translator who could rely accurate information to the participant for the consent or throughout the study.
Where this trial is running
Fort Collins, Colorado
- Colorado State University — Fort Collins, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Josiane L Broussard, PhD
- Email: josiane.broussard@colostate.edu
- Phone: 9704913103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease, Insulin Sensitivity, Shift work, Sleep, Blood sugar, Metabolism