Sleep, InadequateNCT06158204
Improving Metabolic & Mental Health in Female Healthcare Shift Workers
A study testing Lifestyle Intervention in people with Sleep, Inadequate and Overweight and Obesity, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Inadequate, Overweight and Obesity, Work Related Stress
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night 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.
Read the 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."
- Being tested
- Lifestyle Intervention
- Keywords
- circadian rhythm, protein, shift work, female, sleep
- Medical subject headings
- Sleep Deprivation, Overweight, Obesity, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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"
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Participants will receive the 8-week intervention first, followed by 8 weeks of observation-only Receives: Behavioral: Lifestyle Intervention |
| Delayed intervention | Active comparator | Participants will receive the 8-week intervention after 8 weeks of observation-only Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Change from 0-8 weeks; 8-16 weeks
Secondary outcomes (8)
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.
Measured: Change from 0-8 weeks; 8-16 weeks
Fasting alanine aminotransferase (ALT)
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.
Measured: 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.
Measured: 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.
Measured: Change from 0-8 weeks; 8-16 weeks
Sleep - accelerometry
Average minutes of total daily sleep.
Measured: 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).
Measured: 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).
Measured: Change from 0-8 weeks; 8-16 weeks
Stool microbiome composition
16S changes in microbiome alpha diversity.
Measured: Change from 0-8 weeks; 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start2 Jan 2024
- Primary completion19 Jun 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep, InadequateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Fruge, Auburn University
- Investigators
- Andrew D Frugé, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158204
- Sponsor's protocol ID
- 23-496 MR 2310
- Status last verified
- Jul 2024
- First submitted
- 28 Nov 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41228416
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Crossover Lifestyle Intervention to Improve Metabolic & Mental Health in Female Healthcare Night Shift Workers
- ClinicalTrials.gov ID
- NCT06158204
- Acronym / sponsor ID
- 23-496 MR 2310
- Keywords
- circadian rhythm, protein, shift work, female, sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: Lifestyle InterventionParticipants will receive the 8-week intervention first, followed by 8 weeks of observation-only |
| Delayed intervention | Active comparator | Behavioral: Lifestyle InterventionParticipants will receive the 8-week intervention after 8 weeks of observation-only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionParticipants 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" | Behavioural | Delayed intervention, Immediate intervention |
Primary outcome
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.
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).
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).
8 secondary outcomes
Fasting serum triglycerides
Time frame: Change from 0-8 weeks; 8-16 weeks
Fasting alanine aminotransferase (ALT)
Time frame: Change from 0-8 weeks; 8-16 weeks
Fasting serum blood glucose
Time frame: Change from 0-8 weeks; 8-16 weeks
Fasting serum low-density lipoproteins (LDL)
Time frame: Change from 0-8 weeks; 8-16 weeks
Sleep - accelerometry
Time frame: Change from 0-8 weeks; 8-16 weeks
Total caloric intake
Time frame: Change from 0-8 weeks; 8-16 weeks
Total protein intake
Time frame: Change from 0-8 weeks; 8-16 weeks
Stool microbiome composition
Time frame: Change from 0-8 weeks; 8-16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 41228416Robinson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Frugé, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Sleep, Inadequate and Overweight and Obesity, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral fat percentage (time frame: Change from 0-8 weeks; 8-16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.