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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
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3,12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosed sleep disorder or severe insomnia.
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I do not have severe lung, kidney, or heart disease, and I am not currently ill.
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I have a history of seizures.
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I have had weight loss surgery or am on weight loss medication.
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I drink more than the recommended weekly alcohol limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3,12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence
Body weight
Energy intake
+5 more
Secondary study objectives
Diet composition by ASA24
Free fatty acids (FFA)
Inflammation markers
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRE
2023
N/A
~50

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,270 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,128 Total Patients Enrolled
New York UniversityOTHER
240 Previous Clinical Trials
220,217 Total Patients Enrolled

Media Library

HABIT Clinical Trial Eligibility Overview. Trial Name: NCT04465721 — N/A
Prediabetes Research Study Groups: HABIT Group, TRE Group
Prediabetes Clinical Trial 2023: HABIT Highlights & Side Effects. Trial Name: NCT04465721 — N/A
HABIT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04465721 — N/A
~15 spots leftby Dec 2025
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