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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

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
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I can walk, eat by myself, undergo tests, and understand consent forms.
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I am between 40 and 75 years old and live independently.
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I am between 40 and 75 years old and live independently.
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I speak English.
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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:
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I have a history of colorectal cancer, bowel surgery, multiple polyps, or chronic bowel inflammation.
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I have a serious medical condition like cancer, heart, kidney disease, or diabetes.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,596 Total Patients Enrolled
20 Trials studying Obesity
15,632 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,930 Total Patients Enrolled
49 Trials studying Obesity
32,168 Patients Enrolled for Obesity
Terry Hartman, PhD, MPH, RDPrincipal Investigator - Emory University
Emory University

Media Library

High Fiber Diet (HFD) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04780477 — N/A
Obesity Research Study Groups: High Fiber Diet Featuring Legumes (HLD), Healthy American Diet Control Arm
Obesity Clinical Trial 2023: High Fiber Diet (HFD) Highlights & Side Effects. Trial Name: NCT04780477 — N/A
High Fiber Diet (HFD) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04780477 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04780477 — N/A
~16 spots leftby Sep 2025
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