NCT03504683.

Study name	Effect of time‐restricted feeding on 24‐hour glycemic control, blood pressure, and cardiovascular disease risk factors
Methods	Randomised controlled trial
Participants	144 participants Ages Eligible for Study: 30 years to 65 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no Inclusion Criteria Aged 30‐65 years old Prediabetic as determined by HbA1c between 5.7‐6.4% or fasting glucose between 100‐125 mg/dL BMI between 27‐43 kg/m^2 Wake up at a regular time between 5 am‐ to 8 am
Interventions	Arm Intervention/treatment Experimental: Early Time‐Restricted FeedingBehavioural: Early Time‐Restricted Feeding Eat between 8 am ‐ 3 pm (or 7 am ‐ 2 pm, if an early riser) Other names: eTRF Early TRF Experimental: Mid‐day Time‐Restricted FeedingBehavioural: Mid‐day Time‐Restricted Feeding Eat between 1 pm ‐ 8 pm (or 12 pm ‐ 7 pm, if an early riser) Other names: mTRF Mid‐day TRF Placebo Comparator: Control ScheduleBehavioural: Control Schedule Eat between 8 am ‐ 8 pm (or 7 am ‐ 7 pm, if an early riser)
Outcomes	Primary outcome measures: Mean 24‐hour glucose levels [ Time Frame: 10 weeks ] Mean 24‐hour glucose levels (mg/dl) Mean 24‐hour insulin levels [ Time Frame: 10 weeks ] Mean 24‐hour insulin levels (mU/L) Mean 24‐hour C‐peptide levels [ Time Frame: 10 weeks ] Mean 24‐hour C‐peptide levels (pmol/L). This is also a proxy for total 24‐hour insulin secretion. Insulin sensitivity [ Time Frame: 10 weeks ] Mean value of insulin sensitivity (dl/kg/min/μU/mL) across the three identical meal tolerance tests, as measured by the Oral Minimal Model Beta‐cell responsivity index (a measure of beta‐cell function) [ Time Frame: 10 weeks ] Mean value of beta‐cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model Glucose AUCs [ Time Frame: 10 weeks ] Glucose area‐under‐the‐curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24‐hour period Insulin AUC [ Time Frame: 10 weeks ] Insulin area‐under‐the‐curve (mU/L x hour) during each of three identical meal tolerance tests within a 24‐hour period C‐peptide AUC [ Time Frame: 10 weeks ] C‐peptide area‐under‐the‐curve (pmol/L x hour) during each of three identical meal tolerance tests within a 24‐hour period Peak glucose and mean amplitude of glycaemic excursions (MAGE) glucose values [ Time Frame: 10 weeks ] mg/dl Secondary Outcome Measures: Mean 24‐hour systolic and diastolic blood pressure [ Time Frame: 10 weeks ] mmHg Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure [ Time Frame: 10 weeks ] mmHg Percentage of individuals with non‐dipping blood pressure phenotypes [ Time Frame: 10 weeks ] Heart Rate [ Time Frame: 10 weeks ] beats per minute Lipids [ Time Frame: 10 weeks ] Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) High Sensitivity C‐Reactive Protein (hs‐CRP) [ Time Frame: 10 weeks ] mg/L Cortisol [ Time Frame: 10 weeks ] μg/dL 8‐isoprostane [ Time Frame: 10 weeks ] pg/ml Inflammatory biomarkers [ Time Frame: 10 weeks ] TNF‐alpha, IL‐1beta, IL‐4, IL‐6, IL‐10 (in pg/ml) Other Outcome Measures: Fat mass and lean mass [ Time Frame: 10 weeks ] Changes in fat mass and lean mass as measured by dual‐energy X‐ray absorptiometry (DXA) Body weight [ Time Frame: 10 weeks ] Change in body weight (kg) as measured by scale weight Bone mineral density [ Time Frame: 10 weeks ] Changes in bone mineral density (g/cm^2) as measured by dual‐energy X‐ray absorptiometry (DXA) Chronotype [ Time Frame: 10 weeks ] Chronotype (i.e., mid‐point of sleep in clock time) as measured by the Munich Chronotype Questionnaire Sleep Quality [ Time Frame: 10 weeks ] 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.)
Starting date	April 2020
Contact information	cpeterso@uab.edu
Notes	NCT03504683