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Time-Restricted Eating vs Traditional Dieting for Obesity (NY-TREAT Trial)
N/A
Recruiting
Led By Blandine Laferrère, M.D., Ph.D.
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Diagnosis of dyslipidemia on stable regimen
- Diagnosis of hypertension on stable medication regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3,12 months
Awards & highlights
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.
Who is the study for?
This trial is for English-speaking adults aged 50-75 in the NYC area, with a BMI of 25-45 and conditions like hypertension, prediabetes or type 2 diabetes controlled by diet/metformin. Participants should have stable weight, eat breakfast habitually, and own a smartphone. Exclusions include smokers, those with severe diseases or sleep disorders, previous bariatric surgery patients, heavy alcohol consumers, and certain medication users.Check my eligibility
What is being tested?
The study compares two eating patterns to improve heart health and metabolism in overweight individuals: Time Restricted Eating (TRE) where participants eat within a 10-hour window versus their usual pattern (HABIT) of eating over a span of about 13 hours daily. The focus is on whether TRE can better reduce cardiovascular risks.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include hunger pangs during fasting periods with TRE; changes in energy levels; headaches; dizziness due to changes in meal timing which could affect blood sugar levels.
NY-TREAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with dyslipidemia and am on a stable treatment plan.
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I have high blood pressure and am on a stable medication plan.
Select...
I usually sleep for 6 hours, wake up after 5 AM but before 11 AM, and go to bed before 2 AM.
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I am between 50 and 75 years old.
NY-TREAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 3,12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3,12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Body weight
Energy intake
+5 moreSecondary outcome measures
Diet composition by ASA24
Free fatty acids (FFA)
Inflammation markers
+6 moreNY-TREAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TRE GroupExperimental Treatment1 Intervention
Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h).
Group II: HABIT GroupActive Control1 Intervention
Participants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h).
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,694 Previous Clinical Trials
28,027,263 Total Patients Enrolled
43 Trials studying Obesity
12,692 Patients Enrolled for Obesity
Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,447,682 Total Patients Enrolled
41 Trials studying Obesity
6,044 Patients Enrolled for Obesity
New York UniversityOTHER
227 Previous Clinical Trials
312,907 Total Patients Enrolled
6 Trials studying Obesity
3,018 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: HABIT Group
- Group 2: TRE Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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