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Time-Restricted Eating vs Traditional Dieting for Obesity (NY-TREAT Trial)
NY-TREAT Trial Summary
This trial will compare the effects of two different types of diets on weight loss, metabolism, and circadian biology in adults who are overweight or obese. The first diet is a time-restricted diet, where people eat whatever they want but only during a 10-hour window each day. The second diet is a more traditional diet where people eat whatever they want but try to limit their overall daily calorie intake. The investigators hypothesize that the time-restricted diet will be more effective than the traditional diet in terms of weight loss and improvement of metabolism.
NY-TREAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNY-TREAT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NY-TREAT Trial Design
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Who is running the clinical trial?
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- You have a history of serious eating or mental health problems.I have a diagnosed sleep disorder or severe insomnia.I do not have severe lung, kidney, or heart disease, and I am not currently ill.I have been diagnosed with dyslipidemia and am on a stable treatment plan.I have a history of seizures.You have a very late bedtime (after 2AM) or wake up very early (before 5AM), or you have a very late wake up time (after 11AM).I have prediabetes or Type 2 Diabetes managed with diet or metformin.I have high blood pressure and am on a stable medication plan.You have at least two of the following health conditions: high blood pressure, high blood sugar, excess body fat around the waist, high cholesterol.Your blood pressure is higher than 120/80 mmHg.I usually sleep for 6 hours, wake up after 5 AM but before 11 AM, and go to bed before 2 AM.I have had weight loss surgery or am on weight loss medication.I drink more than the recommended weekly alcohol limit.I cannot stay overnight or frequently travel for tests.Your triglyceride levels are higher than 150 mg/dL.I am between 50 and 75 years old.You have serious food allergies.Your weight has stayed about the same for the past 3 months, not changing by more than 5%.You have an iPhone or Android smartphone.You regularly eat breakfast.You regularly eat breakfast.You smoke tobacco or use illegal or recreational drugs.Your hemoglobin and hematocrit levels are too low.Men with a waist size over 40 inches and women with a waist size over 35 inches.I am not taking supplements or medications that affect my sleep or metabolism.Your body mass index (BMI) is between 25 and 45.I speak English.Your "good" cholesterol levels are too low.You need to log your activities at least twice a day on 70% of the days, with each entry being at least 5 hours apart.
- Group 1: HABIT Group
- Group 2: TRE Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are any openings currently available in this research study?
"Affirmative, the clinical trial is actively recruiting. As shown on clinicaltrials.gov, it was initially posted in May 2021 and has been consistently updated up until August 2022. The required patient pool stands at 52 individuals across a single site."
How many volunteers have registered for this experiment?
"Affirmative. Clinicaltrials.gov contains evidence that this trial is recruiting participants, which began on May 26th 2021 and was last updated August 3rd 2022. This medical study will accept no more than 52 volunteers at a single site."
Does this research accept individuals older than 50 years of age?
"This trial is seeking out individuals between the ages of 50 and 70."
What benefits is this trial seeking to confer?
"This research trial will assess glucose variability over a 0, 3 and 12 month period as the primary outcome. Supplementary outcomes include Insulinogenic Index (calculated by insulin/glucose AUC during OGTT), Lipid Profile (measured from fasting blood sample) and Free Fatty Acids (FFA; measured from fasting blood samples)."
Who meets the qualifications to partake in this medical research?
"This trial requires 52 people aged between 50 and 70 who possess impaired glucose tolerance. Additionally, they must have a BMI in the range of 25-45 kg/m2, diagnosis of hypertension on stable medication regimen, blood pressure >120/>80 mmHg, A diagnosis of dyslipidemia on stable regimen with triglycerides 150 mg/dL; waist circumference men: >102 cm (>40 inches); women >88 cm (>35 inches), access to either an iPhone or Android smart phone, adherence to logging for at least 70% days (with 2 or more log entries per day spaced by 5 hours minimum) as well as HDL"
Who else is applying?
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What portion of applicants met pre-screening criteria?
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