Time restricted eating for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+3 MoreTime restricted eating - Behavioral
Eligibility
45 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will show that time-restricted eating, a type of intermittent fasting, is an effective way to help obese people lose weight and prevent colorectal cancer.

Eligible Conditions
  • Obesity
  • Colorectal Cancer
  • Intermittent Fasting
  • Weight Loss

Treatment Effectiveness

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Month 6 to month 12

Baseline to month 6
Weight change (% kg)
Month 12
Total and regional body fat composition and distribution
Month 12
Insulin
HOMA-IR
Month 12
CD3, CD163, pIKKa/b, tissue markers of inflammation
Colonic mucosa gene expression profiling
Fasting plasma glucose
Ki-67, proliferation
Plasma 8-isoprostane
Plasma cytokines TNF-α, IL-6, IL1-β, and IL-10, %
c-caspase-3, Bax, apoptosis
Month 12
Weight maintenance (% kg)
Monthly, through month 6
Intervention adherence

Trial Safety

Trial Design

3 Treatment Groups

Control
1 of 3
Calorie Restriction (Cal-R)
1 of 3
Time Restricted Eating (TRE)
1 of 3

Active Control

Experimental Treatment

255 Total Participants · 3 Treatment Groups

Primary Treatment: Time restricted eating · No Placebo Group · N/A

Time Restricted Eating (TRE)
Behavioral
Experimental Group · 1 Intervention: Time restricted eating · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Calorie Restriction (Cal-R)
Behavioral
ActiveComparator Group · 1 Intervention: Calorie Restriction · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2018
N/A
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 6 to month 12

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,216 Total Patients Enrolled
43 Trials studying Obesity
21,322 Patients Enrolled for Obesity
University of Illinois at ChicagoLead Sponsor
539 Previous Clinical Trials
1,551,132 Total Patients Enrolled
30 Trials studying Obesity
9,269 Patients Enrolled for Obesity
Lisa Tussing-Humphreys, PhD, MS, RDPrincipal InvestigatorUniversity of Illinois at Chicago
2 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Obesity
17 Patients Enrolled for Obesity

Eligibility Criteria

Age 45 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have prediabetes or insulin resistance.
You have been up to date with CRC screening.

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Illinois at Chicago100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email100.0%
Most responsive sites:
  1. University of Illinois at Chicago: < 48 hours