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Time-Restricted Eating vs. Calorie Restriction for Weight Loss and Colorectal Cancer Risk Reduction
N/A
Recruiting
Led By Lisa Tussing-Humphreys, PhD, MS, RD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
45-70 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, month 6, month 9, month 12
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 45-65 with obesity (BMI 30-49.99) who are prediabetic or insulin resistant, and those at elevated risk for colorectal cancer due to recent polyps. Participants must be up to date with CRC screening and not on any weight loss program, drug abuse, or have a history of certain diseases like renal disease or cancer treatment within the last year.Check my eligibility
What is being tested?
The study compares two weight loss methods: daily calorie restriction versus time-restricted eating (a form of intermittent fasting), to see which is more effective in reducing body weight and lowering the risk markers for colorectal cancer in obese individuals.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include hunger, fatigue, irritability, headache during fasting periods; nutritional deficiencies if diet isn't well-balanced; possible gastrointestinal discomfort from changes in eating patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3, month 6, month 9, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6, month 9, month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight change (% kg)
Secondary outcome measures
CD3, CD163, pIKKa/b, tissue markers of inflammation
Colonic mucosa gene expression profiling
Fasting plasma glucose
+12 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Time Restricted Eating (TRE)Experimental Treatment1 Intervention
During the active weight loss period, the TRE group will be instructed to eat ad libitum from 12:00pm - 8:00pm daily and fast from 8:00pm - 12:00pm. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. During the fasting period, participants will be encouraged to drink plenty of water and may consume energy-free beverages, such as black tea or coffee. TRE subjects will meet with the TRE dietitian for 30 minutes at the start of the intervention to review instructions and goals, and then every week throughout the active weight loss period to review intervention adherence. At the beginning of the maintenance phase, total energy needs will be reassessed. Subjects will be instructed to main their body weight by consuming meals in an extended 10-h eating window every day and water fast between 8pm and 10 am, respectively.
Group II: ControlActive Control1 Intervention
Controls will be instructed to maintain their weight throughout the 12 m trial and to not change eating or physical activity habits. Controls will not receive dietary counseling. Controls will visit the research center monthly for outcome measurements.
Group III: Calorie Restriction (Cal-R)Active Control1 Intervention
Cal-R subjects will be instructed to restrict energy intake by 25% of their baseline total energy expenditure (TEE) daily. Subjects will meet with a study dietitian for a 60-min one-on-one session to develop individualized weight loss meal plans to help them adhere to their calorie restriction goal. Meal plans will include portion sizes and food lists that are consistent with their food preferences and prescribed calorie levels for weight loss. Food scales will be provided to help with food portioning. Cal-R subjects will meet with the dietitian every week throughout the weight loss period to review intervention adherence and modify the meal plans as needed. Subjects will be asked to maintain their baseline level of physical activity. At the beginning of the weight maintenance phase, total energy needs will be reassessed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2021
N/A
~130
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,599 Total Patients Enrolled
48 Trials studying Obesity
31,233 Patients Enrolled for Obesity
University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,054 Total Patients Enrolled
33 Trials studying Obesity
9,568 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious health issues like kidney disease, autoimmune disorders, or severe heart and lung conditions.I am between 45 and 65 years old with a BMI between 30 and 49.99.I have been treated for cancer or have a genetic risk for colorectal cancer in the last year.I am not on any weight loss medications.I am at high risk for colorectal cancer due to having 3 or more polyps or a large polyp in the last 5 years.I am perimenopausal or have an irregular menstrual cycle.I am between 45 and 70 years old.I am currently on blood thinners or medications that increase bleeding risk.I am currently on antiviral or immunosuppressant medications.My diabetes is under control, or I might have undiagnosed diabetes with HbA1c over 9%.You have been up to date with CRC screening.You have prediabetes or insulin resistance.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Time Restricted Eating (TRE)
- Group 3: Calorie Restriction (Cal-R)
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.
Obesity Patient Testimony for trial: Trial Name: NCT05114798 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still space available for participants of this research?
"Confirmed, this trial is still accepting participants. On May 17th 2022, the study was first posted and its contents last revised on August 22nd 2022."
Answered by AI
Does this research involve any geriatric individuals?
"To qualify for this trial, individuals must be between the ages of 45-65."
Answered by AI
What is the overall size of the population involved in this clinical trial?
"Affirmative. The clinicaltrials.gov platform reveals that enrollment for this trial opened on May 17th 2022 and is still ongoing, as the study was most recently updated on August 22nd of the same year. 255 patients are planned to be recruited from a single site."
Answered by AI
For whom is this scientific research appropriate?
"To qualify for this trial, potential participants must have a BMI above the normal range and fall between 45-65 years of age. This medical experiment is hoping to enroll 255 patients in total."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Illinois
How old are they?
18 - 65
What site did they apply to?
University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I’ve struggled with obesity since peri menopause and have tried intermittent fasting with little success. My concern is losing muscle and bone density due to aging.
PatientReceived no prior treatments
I’ve tried regular dieting and doesn’t seem to work for me. Looking for a better way to lose weight and keep it off. I’m afraid my weight is badly influencing my health.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screenings take? Are expenses reimbursed? What is the time frame for each visit?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- University of Illinois at Chicago: < 48 hours
Average response time
- < 2 Days
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