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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMean 24-hour glucose levels
Mean 24-hour glucose levels (mg/dl)
Time frame: 8 weeks
Mean 24-hour insulin levels
Mean 24-hour insulin levels (mU/l)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
C-peptide AUC
C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period
Time frame: 8 weeks
Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values
mg/dl
Time frame: 8 weeks
Mean 24-hour systolic and diastolic blood pressure
mmHg
Time frame: 8 weeks
Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure
mmHg
Time frame: 8 weeks
Percentage of individuals with non-dipping blood pressure phenotypes
Time frame: 8 weeks
Heart Rate
beats per minute
Time frame: 8 weeks
Lipids
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Time frame: 8 weeks
High Sensitivity C-Reactive Protein (hs-CRP)
mg/l
Time frame: 8 weeks
Cortisol
μg/dl
Time frame: 8 weeks
8-isoprostane
pg/ml
Time frame: 8 weeks
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