Clinical trial NCT03956290: Time Restricted EATing (TREAT) Pilot Study
Official title: Time Restricted EATing (TREAT) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Pre Diabetes
Keywords: Time restricted eating
Overweight
Obesity
Metabolic syndrome
Diabetes treated with metformin and/or diet and HbA1C< 7%
Pre Diabetes
Circadian rhythm
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.

Detailed description: Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.

Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.

Eligibility criteria: Inclusion Criteria:

* age: 45-73y old
* overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
* pre-diabetes or diabetes only diet controlled (HbA1c \<7%)
* elevated Blood Pressure (BP) 120-129/\<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk \<10%
* having LDL cholesterol \<150mg/dl
* no known sleep, psychiatric or food intake disorders
* in possession of a smart phone
* English-speaking
* must live in New York city geographical area and not have planned travel schedule interfering with the study

Exclusion Criteria:

* history or clinical evidence of condition that affect sleep
* significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
* history of seizure disorder
* being on medications for diabetes, hypertension or dyslipidemia
* previous bariatric surgery
* history or current significant psychiatric disorder
* use 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)
* consume large amounts of caffeine daily (\>2 cups of coffee or 8 oz caffeinated drinks per day)
* participate in intense exercise (causing heavy breathing and sweating, such as jogging) \>2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for \>150 min/wk
* shift work
* extreme early and late chronotypes
* unwilling/unable to provide informed consent

Primary outcomes:
measure: Percentage of participants logging
timeFrame: 3 months
measure: Percentage of patients who reduced eating duration by 4 hours
timeFrame: 3 months
Secondary outcomes:
measure: % weight loss achieved post-intervention
timeFrame: Baseline to 3 months
measure: Average time in duration of overnight fasting
timeFrame: 3 months
measure: Average time in sleep duration
timeFrame: 3 months
measure: Adherence to using the app
timeFrame: 3 months
measure: % of participants who achieve ≥ 5% weight loss
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Obesity Nutrition Research Center
state: New York
Study officials:
affiliation: Columbia University
name: Blandine Laferrère, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prasad M, Fine K, Gee A, Nair N, Popp CJ, Cheng B, Manoogian ENC, Panda S, Laferrere B. A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Nutrients. 2021 Jun 23;13(7):2148. doi: 10.3390/nu13072148.