Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    70
  • sponsor
    Emory University
Updated on 15 June 2022
cancer

Summary

The study will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.

Description

The goal of the research is to conduct a clinical trial featuring study-provided pre-portioned entrées (2 entrées per day months 1-3, 1 entrée per day months 4-6) and strategic nutritional instruction to guide participants to integrate legumes into a healthy high-fiber diet pattern. The research will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years, to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.

Details
Condition Colon Cancer, Obesity
Treatment Experimental: High Fiber Diet (HFD), Healthy American Diet
Clinical Study IdentifierNCT04780477
SponsorEmory University
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

free-living adults 40-75 yrs. old
BMI 25-40 kg/m2
colonoscopy within 3 years that found ≥1 adenoma >0.5 cm
English speaking
ambulatory, able to pick up food, participate in clinical exams and laboratory tests - able to provide informed consent

Exclusion Criteria

serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes,)
history of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
smoked regularly in the past year
dietary restrictions substantially limiting compliance (e.g., must be willing to be randomized to either diet)
planning on substantially changing usual exercise behavior in the next 6 mos
regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (e.g., non-steroidal anti-inflammatory drugs, antibiotics, insulin, steroids)
pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note