NCT04057339.

Study name	The Influence of time‐restricted eating in patients with Metabolic Syndrome (TIMET)
Methods	Randomised controlled trial
Participants	144 participants
Interventions	Arm Intervention/treatment Placebo comparator: SOC (Standard of Care) Everyone in this arm will receive standard of care nutritional behavioural counselling and will be required to log their caloric intake through the use of a smartphone app. Behavioural: SOC Participants in this arm will receive nutritional counselling from the study dietician, but will not be required to adopt a 10‐hOUr eating window. Experimental: TRE + SOC Everyone in this arm will receive SOC nutritional behavioural counselling and will implement a daily 10‐hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app. Behavioural: TRF + SOC Participants in this arm will adhere to a daily, consistent 10‐hour eating window for the course of the study as well as receive nutritional counselling from the study dietitian. Other name: Time Restricted Eating
Outcomes	Primary Outcome Measures : Change in fasting glucose [ Time Frame: Baseline and 14 weeks ] Fasting glucose (mg/dl) Change in fasting glucose levels [ Time Frame: Baseline and 14 weeks ] Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline and end of intervention Secondary Outcome Measures: Change in LDL particle number [ Time Frame: Baseline and 14 weeks ] LDL particle number (nmol/L) via NMR lipoprofile Change in LDL cholesterol [ Time Frame: Baseline and 14 weeks ] LDL cholesterol (mg/dl) Change in HDL cholesterol [ Time Frame: Baseline and 14 weeks ] HDL cholesterol (mg/dl) Change in Triglycerides [ Time Frame: Baseline and 14 weeks ] Triglycerides (mg/dl) Change in % fat mass [ Time Frame: Baseline and 14 weeks ] Fat mass as measured by dual‐energy X‐ray absorptiometry (DXA) Change in hs‐CRP [ Time Frame: Baseline and 14 weeks ] high sensitivity C‐reactive protein (mg/L) Change in HbA1c [ Time Frame: Baseline and 14 weeks ] HbA1c (%)
Starting date	April 8, 2019
Contact information	Ages Eligible for Study: 18 years to 75 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no Inclusion Criteria Age 18‐75 years BMI > 25 and Metabolic syndrome, as defined as presence of 3 or more of the following criteria. Elevated fasting plasma glucose ≥ 100 mg/dL Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women. Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High‐density lipoprotein (HDL)‐cholesterol < 40 mg/dL in males or < 50 mg/dL in females, or drug treatment for reduced HDL‐cholesterol, elevated blood pressure, systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension. Own a smartphone (Apple iOS or Android OS) Baseline eating period > 14 hours/day If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti‐hypertensive, anti‐diabetes drugs), no dose adjustments will be allowed during the study period.
Notes	NCT04057339