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Time Restricted Eating for Weight Loss Maintenance (TWIST Trial)

N/A
Recruiting
Led By Mary A. Sevick, ScD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if restricted eating can help people maintain weight loss. 40 people from 2 clinics will follow either a 6 or 10 hour eating window for 12 weeks. Results measured at 4 and 12 weeks.

Who is the study for?
This trial is for adults aged 25-65 with a BMI of 20.5-45 who have lost at least 5% of their body weight without surgery, are not very physically active, and typically eat over a span of more than 12 hours daily. Excluded are those over 400lbs, pregnant or breastfeeding women, anyone with eating disorders or certain medical conditions like active cancer or severe diabetes.
What is being tested?
The study tests two time-restricted eating plans for maintaining weight loss: one group eats within a 6-hour window (TRE6), the other within a 10-hour window (TRE10). Participants will be randomly assigned to these groups and monitored over a period of up to three months.
What are the potential side effects?
Potential side effects may include hunger outside designated eating times, changes in energy levels throughout the day, potential impact on sleep patterns due to altered meal timing, and possible adjustment-related digestive issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 Rate
Recruitment Rate
Retention Rate
+1 more
Secondary study objectives
Change from Baseline in Fat Mass
Change from Baseline in Lean Mass

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
Group I: Time-Restricted Eating - 6 Hours (TRE6)Experimental Treatment1 Intervention
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Group II: Time-Restricted Eating - 10 Hours (TRE10)Experimental Treatment1 Intervention
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time Restricted Eating (TRE)
2020
N/A
~120

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,849 Total Patients Enrolled
255 Trials studying Obesity
211,626 Patients Enrolled for Obesity
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,153 Total Patients Enrolled
25 Trials studying Obesity
10,579 Patients Enrolled for Obesity
Mary A. Sevick, ScDPrincipal InvestigatorNYU Langone Health

Media Library

Time Restricted Eating (TRE) Clinical Trial Eligibility Overview. Trial Name: NCT05742165 — N/A
Obesity Research Study Groups: Time-Restricted Eating - 10 Hours (TRE10), Time-Restricted Eating - 6 Hours (TRE6)
Obesity Clinical Trial 2023: Time Restricted Eating (TRE) Highlights & Side Effects. Trial Name: NCT05742165 — N/A
Time Restricted Eating (TRE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05742165 — N/A
~0 spots leftby Jan 2025
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