NCT03527368.

Study name	The Time‐Restricted Intake of Meals study (TRIM)
Methods	Randomised controlled trial
Participants	41 participants Ages Eligible for Study: 21 years to 69 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: yes Inclusion Criteria Prediabetes defined by HbA1c 5.7‐6.4%, or type 2 diabetes with HbA1c 6.5‐6.9% Class I‐III obesity (BMI 30‐39.9 kg/m2) If on medications for hypertension, stable regimen for at least past 6 months Willingness to adjust timing of feeding Willingness and ability to eat study diet and nothing else during run‐in and intervention Willingness to complete measurement procedures
Interventions	Arm Intervention/treatment Experimental: Time‐restricted feeding Behavioural: Time‐restricted feeding Participants consume food earlier in the day Usual feeding pattern Comparison Behavioural: usual feeding pattern Participants consume food later in the day
Outcomes	Primary outcome measures: Weight Change [ Time Frame: 12 weeks ] Weight change will be measured in kg Secondary Outcome Measures: Oral glucose tolerance test (OGTT) [ Time Frame: 12 weeks ] Change in 2‐hour glucose on OGTT Blood pressure [ Time Frame: 12 weeks ] 24‐hour ambulatory systolic blood pressure Blood pressure [ Time Frame: 12 weeks ] 24‐hour ambulatory diastolic blood pressure
Starting date	September 24, 2018
Contact information	Nisa Maruthur, MDJohns Hopkins University
Notes	NCT03527368