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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Body Weight
Change in Ki-67+ Level
Secondary outcome measures
Body Weight
Change in CD3+ Intraepithelial Lymphocytes Count
Change in CD68+ Lamina Propia Macrophages Count
+5 moreTrial 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
1,638 Previous Clinical Trials
2,560,462 Total Patients Enrolled
21 Trials studying Obesity
15,652 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,202 Total Patients Enrolled
48 Trials studying Obesity
31,418 Patients Enrolled for Obesity
Terry Hartman, PhD, MPH, RDPrincipal Investigator - Emory University
Emory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk, eat by myself, undergo tests, and understand consent forms.You have a colonoscopy within 3 years that found ≥1 adenoma >0.5 cm.I am between 40 and 75 years old and live independently.I am between 40 and 75 years old and live independently.I speak English.I can walk, eat by myself, and understand and agree to the study's requirements.I have a history of colorectal cancer, bowel surgery, multiple polyps, or chronic bowel inflammation.I regularly take medication that could affect inflammation, insulin, glucose, or my gut.I have a serious medical condition like cancer, heart, kidney disease, or diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy American Diet Control Arm
- Group 2: High Fiber Diet Featuring Legumes (HLD)
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: NCT04780477 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to join this clinical investigation?
"This clinical trial is still open to sign-ups, as per the information on clinicaltrials.gov. It was posted on June 29th 2021 and last updated 8th of June 2022."
Answered by AI
Does this medical experiment accept volunteers over the age of twenty?
"This study is geared towards those aged between 40 and 75. However, there are also 209 trials available for younger participants and 834 trials applicable to elderly individuals."
Answered by AI
How many people are partaking in this experiment at its most populated?
"Indeed, the information posted on clinicaltrials.gov confirms that this trial is still recruiting participants. It was first shared with the public on June 29th 2021 and the last update to its description occurred on June 8th 2022. 70 individuals need to be enrolled in order for it to run at 1 medical site."
Answered by AI
Are my traits suitable for enrollment in this research endeavor?
"This research effort is accepting 70 individuals 40-75 years old with a body mass index between 25 and 40 kg/m2. All participants must lead an independent lifestyle to be eligible for the trial."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Rollins School of Public Health, Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long is the trial for and yes, how long are the sessions?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I'm interested in losing weight. It's getting too hot too much of the year to walk like I would like to at my age. I'm exploring possible options and see the success that some of these clinical trials are producing.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Rollins School of Public Health, Emory University: < 48 hours
Average response time
- < 2 Days
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