Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK139356-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of San Diego | OTHER |
Not provided
Not provided
Not provided
Not provided
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
The purpose of this study is to assess if reducing the number of hours during which participants eat each day, and consolidating dietary intake to the daytime, (with or without a low glycemic snack during night shifts) will help decrease weight and abdominal fat, improve glucose (sugar) regulation, and improve other markers of metabolic and cardiovascular health (i.e. lipid levels, inflammation markers, etc.).
Circadian clocks ("circa" means approximately and "dian" means day) are daily rhythms in physiology and behavior (activity, sleep, eating pattern) that help our body to anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and almost every organ of our body. Remarkably, even in the absence of any timing information from a device, our body can keep track of time and thereby help us go to sleep and eat at optimum times. However, our lifestyle and work schedules can lead us to eat, exercise, and sleep at times that the clocks in our body are not prepared for. When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including increased body weight, poor sleep, and elevated risk for various chronic diseases. Time-restricted eating (TRE), which restricts all dietary intake to a personalized consistent daily eating window to support circadian rhythms, has been shown to improve cardiometabolic health. However, TRE has not yet been assessed in people who work night shifts.
In this study, the investigators are interested in evaluating the effects of modifying eating patterns on the health of nurses and nursing assistants who work night shifts. Participants will be randomized to (1) dietary monitoring alone, or in combination with, (2) personalized 10-hour TRE (TRE), or (3) personalized 10-hour TRE with a low-glycemic snack provided to consume during night shifts (TRE-LGS). The TRE group will only be allowed water, black coffee, and tea (without any additives such as cream, sweetener including artificial sweeteners), during night shifts. The TRE+LGS group will be provided a low glycemic snack during night shifts.
The study is a year-long including a 2-week screening/baseline assessment, a 6-month guided intervention, and a 6-month self-guided intervention. Health assessments will be taken at screening/baseline, 3 months, 6 months (primary outcome), and 1 year (follow-up). Assessments will include weight (in clinic and at home), blood pressure (in clinic and at home), dietary recall (ASA24), body mass index, blood tests (biomarkers of cardiometabolic health parameters), glycemic regulation (Continuous Glucose Monitors), body composition ( duel energy x-ray absorptiometry, DXA), dietary intake (logged on the myCircadianClock smartphone app), sleep and quality of life questionnaires, and activity, sleep, and wrist temperature (actigraphy watch).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Monitoring | Active Comparator | Log all dietary intake and continue habitual eating patterns. |
|
| Time-Restricted Eating (TRE) | Experimental | Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window |
|
| Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS) | Experimental | Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Monitoring | Behavioral | Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Fat Mass (kg) | Total Body Fat Mass (kg) assessed by DXA | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) in clinic | Body weight (kg) measured in clinic while participants are wearing a gown that has been weighed. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Body Mass Index |
| Measure | Description | Time Frame |
|---|---|---|
| Lean Mass (g) | Whole body lean mass (g) assessed by DXA scan | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Percent Body Fat (%) | Whole body percent Body Fat (%) assessed by DXA scan |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCSD Study Coordinator | Contact | 858-246-2342 | research@mycircadianclock.org | |
| Salk Clinical Researcher | Contact | 858-453-4100 | 1077 | research@mycircadianclock.org |
| Name | Affiliation | Role |
|---|---|---|
| Emily Manoogian, Ph.D. | Salk Institute for Biological Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Altman Clinical and Translational Research Institute | Recruiting | La Jolla | California | 92037 | United States |
We will report deidentified individual participant data for outcomes that are reported in scientific publications (text, tables, figures, and appendices).
Data will be available within 1 month of publication with no set end date (minimum of 5 years).
Data will be available to anyone who wants to access it through a data depository that will be disclosed at the time of publication.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time-Restricted Eating (TRE) | Behavioral | Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. |
|
| Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) | Behavioral | Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team. |
|
Body Mass Index (BMI) (kg/m2)
| Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| HbA1c (%) | Hemoglobin A1c (%) from fasted blood draw | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Intra-Daily Glycemic Variability: CONGA (A.U.) | Continuous Overall Net Glycemic Action (CONGA) assessed via continuous glucose monitor | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Inter-Daily Glycemic Variability: MODD (mg/dL) | Mean of Daily Differences (MODD) assessed via continuous glucose monitor | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Glycemic Variability: MAGE (mg/dL) | Mean Amplitude of Glycemic Excursions (MAGE) assessed by continuous glucose monitor | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Mean Glucose (mg/dL) | Mean Glucose assessed by continuous glucose monitor | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Fasting Glucose (mg/dL) | Blood glucose assessed from a fasted blood draw | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Fasting Insulin (uIU/mL) | Blood insulin assessed from a fasted blood draw | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Blood Pressure (mmHg) | Systolic and Diastolic Blood Pressure taken in clinic. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Blood Pressure (mmHg)_at home measurements | Systolic and Diastolic blood pressure taken at home. Measurements are taken twice (one measurement on a work day and one on an off day) during the 2 week assessment periods. Each day measurements will be taken 3 times throughout the day. Averages for work days and off days will be reported for each time point. Averages at each time point will be reported. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Direct LDL Cholesterol (mg/dL) | Direct LDL cholesterol from fasted blood draw | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Non-HDL Cholesterol (mg/dL) | Non-HDL cholesterol from fasted blood draw | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Visceral Adipose Tissue Mass (g) | Whole body Visceral Adipose Tissue Mass (g) assessed by DXA scan | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Body Weight (kg) at home | Participants will weigh themselves every 2 weeks at home on study provided scales in the morning. | From enrollment to the end of the intervention at 1 year. |
| Blood Glucose Time in Range (%) | Time in range (%) from continuous glucose monitor. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Glycemic Management Indicator (%) | Glycemic Management Indicator (GMI, %), an estimate of A1c, from continuous glucose monitor. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Triglycerides (mg/dL) | Triglycerides (mg/dL) from fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Total Cholesterol (mg/dL) | Total cholesterol (mg/dL) from fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| HDL-cholesterol (mg/dL) | HDL-cholesterol (mg/dL) from fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| hs-CRP (mg/dL) | hs-CRP (mg/dL) from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| LDL Particle number (nmol/L) | LDL Particle number (nmol/L) assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Apo A (mg/dL) | Apo A (mg/dL) assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Apo B (mg/dL) | Apo B (mg/dL) assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Apo A/B ratio | Apo A/B ratio assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Very Low Density Lipoprotein (VLDL) Size (nm) | VLDL size (nm) assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| HDL Particle number (umol/L) | HDL Particle number (umol/L) assessed by NMR lipoprotein profiles from a fasted blood draw. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Quality of Life Assessment | Short-Form 36 (SF-36) Survey. Scores range from 0-100 (an average of all questions which each have a 0-100 scale), with 100 indicating better physical and emotional health. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Sleep Duration | Average total daily sleep duration assessed by actigraphy watch | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI). Each item is scored on a 0-3 scale with a total score of 0-21. A lower score indicates better sleep. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Epworth Sleepiness Scale | Epworth Sleepiness Scale (ESS). Scored from 0-24. A lower score indicates less sleepiness. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| Chronotype | Munich Chronotype Questionnaire (MCTQ) Shiftwork estimates an individuals chronotype. | Baseline, 3 month, 6 month (primary), and 12 month (follow-up) |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided