NCT04465721Completed
TREAT to Improve Cardiometabolic Health
New York TREAT (Time Restricted EATing) to Improve Cardiometabolic Health Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 1 Jul 2020
- Start date
- 14 Jun 2021
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Columbia University
- Diseases
- Obesity
- NCT number
- NCT04465721
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 14 Jun 2021 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous bariatric surgery or on weight loss medication
- use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
- smoking tobacco or using illegal or recreational drugs
Other illness
- 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
- history of or current significant food intake or psychiatric disorder
- have conditions that render individual unable to complete all testing procedures \[e.g., unable to stay overnight or frequent travel across 1 time zones\]
- severe food allergies
Lab values
- anemia (hemoglobin \<10 g/dl and hematocrit \<30%)
Other
- consume excessive alcohol (women: \>14 drinks/wk; men: \>21 drinks/wk)
- extreme early and late chronotypes (\> 2AM bed time and wake up time before 5AM and \> 11AM)
- unwilling/unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.