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TRE for Overweight and Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Overweight and Obesity+1 MoreTRE - Behavioral
Eligibility
50 - 70
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Overweight and Obesity
  • Prediabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

8 Primary · 9 Secondary · Reporting Duration: 0, 3,12 months

0, 3 months
Energy intake
Insulinogenic Index
Matsuda Index (Insulin resistance)
0, 3, 12 months
Body weight
Diet composition by ASA24
Free fatty acids (FFA)
Inflammation markers
Insulin resistance (HOMA-IR)
Ketones
Lipid profile
Oxidative stress
Physical activity
Month 12
Fat mass
0, 3,12 months
Adherence
Glucose levels
Glucose variability
Sleep assessment

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.
2
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
3
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Trial Design

2 Treatment Groups

HABIT Group
1 of 2
TRE Group
1 of 2

Active Control

Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: TRE · No Placebo Group · N/A

TRE Group
Behavioral
Experimental Group · 1 Intervention: TRE · Intervention Types: Behavioral
HABIT Group
Behavioral
ActiveComparator Group · 1 Intervention: HABIT · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 3,12 months

Who is running the clinical trial?

Salk Institute for Biological StudiesOTHER
16 Previous Clinical Trials
1,208 Total Patients Enrolled
2 Trials studying Overweight and Obesity
135 Patients Enrolled for Overweight and Obesity
Columbia UniversityLead Sponsor
1,297 Previous Clinical Trials
1,613,185 Total Patients Enrolled
2 Trials studying Overweight and Obesity
96 Patients Enrolled for Overweight and Obesity
New York UniversityOTHER
205 Previous Clinical Trials
313,712 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,414 Previous Clinical Trials
3,484,170 Total Patients Enrolled
3 Trials studying Overweight and Obesity
693 Patients Enrolled for Overweight and Obesity
Blandine Laferrère, M.D., Ph.D.Principal InvestigatorColumbia University

Eligibility Criteria

Age 50 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have hypertension.
You have a diagnosis of dyslipidemia on a stable regimen.
You have 70% or more of days with logging adherence.
You have low HDL cholesterol.
References

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