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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

Must not have

Have a history of renal disease, autoimmune disorders, immunodeficiency, malabsorptive disorder, significant gastrointestinal and hepatic disease, surgical change in gastrointestinal anatomy, severe ischemic heart disease, severe pulmonary disease, severe mental health disorder, eating disorder, or bariatric surgery

Are taking drugs that influence study outcomes (weight loss medications)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, month 6, month 9, month 12

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am between 45 and 70 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 history of serious health issues like kidney disease, autoimmune disorders, or severe heart and lung conditions.

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I am not on any weight loss medications.

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I am currently on antiviral or immunosuppressant medications.

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My diabetes is under control, or I might have undiagnosed diabetes with HbA1c over 9%.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6, month 9, month 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

Weight change (% kg)

Secondary study objectives

CD3, CD163, pIKKa/b, tissue markers of inflammation

Colonic mucosa gene expression profiling

Fasting plasma glucose

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 every 3 months 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

0 / 5Eligibility criteria met