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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK118236 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between ~8 am-3 pm), (2) 'Mid-day TRE' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early TRE | Experimental |
| |
| Mid-day TRE | Experimental |
| |
| Control Schedule | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early TRE | Behavioral | Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser) |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour glucose levels | Mean 24-hour glucose levels (mg/dl) | 8 weeks |
| Mean 24-hour insulin levels | Mean 24-hour insulin levels (mU/l) | 8 weeks |
| Mean 24-hour C-peptide levels | Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion. | 8 weeks |
| Insulin sensitivity | Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model | 8 weeks |
| Beta-cell responsivity index (a measure of beta-cell function) | Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model | 8 weeks |
| Glucose AUCs | Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period | 8 weeks |
| Insulin AUC | Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period | 8 weeks |
| C-peptide AUC |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour systolic and diastolic blood pressure | mmHg | 8 weeks |
| Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure | mmHg |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Percent adherence to assigned meal timing group | 8 weeks |
| Body weight | Change in body weight (kg) as measured by scale weight | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney M. Peterson, Ph.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.
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| Mid-day TRE | Behavioral | Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser) |
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| Control Schedule | Behavioral | Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser) |
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C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period
| 8 weeks |
| Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values | mg/dl | 8 weeks |
| 8 weeks |
| Percentage of individuals with non-dipping blood pressure phenotypes | 8 weeks |
| Heart Rate | beats per minute | 8 weeks |
| Lipids | Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) | 8 weeks |
| High Sensitivity C-Reactive Protein (hs-CRP) | mg/l | 8 weeks |
| Cortisol | μg/dl | 8 weeks |
| 8-isoprostane | pg/ml | 8 weeks |
| Appetite across the day | Subjective appetite as measured by Visual Analog Scales across the waking day | 8 weeks |
| Appetite | Subjective appetite as measured by retrospective Visual Analog Scales (VAS) | 8 weeks |
| Appetite and Cravings | Subjective appetite and cravings as measured by Likert scales | 8 weeks |
| Eating Self-Efficacy | Eating self-efficacy as measured by the Weight Loss Efficacy Lifestyle Questionnaire (WEL-8) | 8 weeks |
| Sleepiness | Sleepiness as measured by the Karolinska Sleepiness Scale (KSS) across the waking day | 8 weeks |
| Current and Preferred Eating Times | Current and preferred eating times as measured by a custom designed chrononutrition questionnaire | 8 weeks |
| Mood | Mood as measured by the Visual Analog Mood Scales (VAMS) | 8 weeks |
| Positive Affect | Positive Affect as measured by the PROMIS Positive Affect Short Form (PASF) | 8 weeks |
| Stress | Stress as measured by the Perceived Stress Scale (PSS) | 8 weeks |
| Anxiety | Anxiety as measured by the General Anxiety Disorder-7 (GAD-7) | 8 weeks |
| Depression | Depression as measured by the Patient Health Questionnaire-9 (PHQ-9) | 8 weeks |
| Sleep Quality | Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.) | 8 weeks |
| Sleep Timing, Duration, and Chronotype | Sleep timing and duration as measured by the Munich Chronotype Questionnaire (MCTQ) | 8 weeks |
| Chronotype | Chronotype as assessed by the reduced Morningness-Eveningness Questionnaire (rMEQ) | 8 weeks |
| GPAQ | Physical activity as assessed by the General Physical Activity Questionnaire (GPAQ) | 8 weeks |
| Exit Interview | Qualitative data on experiences with the eating schedules and barriers, facilitators, and satisfaction factors | 8 weeks |
| Sleep timing outcomes | Sleep duration, sleep timing, sleep latency, and wake after sleep onset as measured by actigraphy watch. (These all have units of time) | 8 weeks |
| Sleep efficiency and disruption | Sleep efficiency (%) and awakenings (no.), as measured by actigraphy watch. (These all have dimensionless units.) | 8 weeks |
| Other sleep outcomes | Sleep Fragmentation Index (awakenings per time), as measured by actigraphy watch | 8 weeks |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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