TREAT to Improve Cardiometabolic Health
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.
Conditions:
🦠 Overweight and Obesity 🦠 Prediabetes
🗓️ Study Start (Actual) 14 June 2021
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 62
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * age: 50-75y old
    • * BMI ≥25 and ≤45 kg/m2
    • * a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:
    • * diagnosis of hypertension on stable medication regimen
    • * blood pressure \>120/\>80 mmHg
    • * A diagnosis of dyslipidemia on stable regimen
    • * triglycerides 150 mg/dL
    • * HDL cholesterol men \<40 mg/dL and women \<50 mg/dL
    • * waist circumference men: \>102 cm (\>40 in); women \>88 cm (\>35 in)
    • * in possession of a smart phone (iPhone or Android)
    • * 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
    • * Sleep duration 6-h, with habitual self-reported wake up time \>5AM and before 11 AM and average self reported bed time \<2AM
    • * habitually eat breakfast
    • * with weight stability within 5% of screening for the last 3 months
    • * English speaking (the App has not yet been translated)
    • * must live in the New York City metro area

    Exclusion Criteria:

    • * sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index \>30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
    • * significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
    • * history of seizure disorder
    • * previous bariatric surgery or on weight loss medication
    • * history of or current significant food intake or psychiatric disorder
    • * use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
    • * smoking tobacco or using illegal or recreational drugs
    • * consume excessive alcohol (women: \>14 drinks/wk; men: \>21 drinks/wk)
    • * anemia (hemoglobin \<10 g/dl and hematocrit \<30%)
    • * have conditions that render individual unable to complete all testing procedures \[e.g., unable to stay overnight or frequent travel across 1 time zones\]
    • * extreme early and late chronotypes (\> 2AM bed time and wake up time before 5AM and \> 11AM)
    • * severe food allergies
    • * unwilling/unable to provide informed consent
Ages Eligible for Study: 50 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 July 2020
  • First Submitted that Met QC Criteria 6 July 2020
  • First Posted 10 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024