← Back to Search

Dietary Supplement

High Fiber Diet for Obesity and Colon Cancer

N/A

Recruiting

Led By Terry Hartman, PhD, MPH, RD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ambulatory, able to pick up food, participate in clinical exams and laboratory tests - able to provide informed consent

Free-living adults 40-75 yrs. old

Must not have

History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease

Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a high-legume, high-fiber diet helps people lose weight and lowers their risk for colorectal cancer.

Who is the study for?

This trial is for English-speaking adults aged 40-75 who are overweight or obese (BMI 25-40), can move around on their own, and have had a colonoscopy that found polyps in the last 3 years. It's not for those with serious health issues like cancer or heart disease, recent smokers, people with dietary restrictions, those changing exercise habits significantly soon, regular users of certain medications affecting gut function or inflammation markers, or women who are pregnant.

What is being tested?

The study tests if a high-legume, high-fiber diet leads to more weight loss and lower intestinal cancer risk markers compared to a standard healthy American diet among individuals at risk for colorectal cancer due to obesity and previous polyps.

What are the potential side effects?

While specific side effects aren't listed for this dietary intervention trial, changes in diet may cause digestive discomfort such as bloating or gas initially as the body adjusts to higher fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk, eat by myself, undergo tests, and understand consent forms.

Select...

I am between 40 and 75 years old and live independently.

Select...

I am between 40 and 75 years old and live independently.

Select...

I speak English.

Select...

I can walk, eat by myself, and understand and agree to the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of colorectal cancer, bowel surgery, multiple polyps, or chronic bowel inflammation.

Select...

I have a serious medical condition like cancer, heart, kidney disease, or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6, month 12

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

Change in Body Weight

Change in Ki-67+ Level

Secondary study objectives

Body Weight

Change in CD3+ Intraepithelial Lymphocytes Count

Change in CD68+ Lamina Propia Macrophages Count

+5 more

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

Active Control

Group I: High Fiber Diet Featuring Legumes (HLD)Experimental Treatment1 Intervention

Participants randomized to the high fiber diet featuring legumes (HLD) will add approximately 30 grams of dietary fiber per day from legume dishes, ensuring a total intake of approximately 50 grams of dietary fiber per day.

Group II: Healthy American Diet Control ArmActive Control1 Intervention

Participants randomized to the healthy American diet control arm will receive pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat.

0 / 7Eligibility criteria met