Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity
NCT05141526
Healthy Eating Attitudes and Behaviours Group Program
NCT04626102
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition
NCT02966444
Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
NCT03612661
Impact of a Satiating Diet in Obese Men With a Low Satiety Phenotype
NCT03128697
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Legume diet group
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
Legume diet group
about 1 1/2 cups of legumes included in lunch and dinner meals
Smartpill
to assess how long food takes to pass through the digestive system
legumes
about 1 1/2 cups of legumes included in lunch and dinner meals
Control diet group
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
Control diet group
no legumes in lunch or dinner meals
Smartpill
to assess how long food takes to pass through the digestive system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Legume diet group
about 1 1/2 cups of legumes included in lunch and dinner meals
Control diet group
no legumes in lunch or dinner meals
Smartpill
to assess how long food takes to pass through the digestive system
legumes
about 1 1/2 cups of legumes included in lunch and dinner meals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Colonoscopy within the last two years that found ≥1 adenoma
* English speaking
* Ambulatory, able to come to either food distribution site to pick up food and participate in clinical examinations and laboratory tests
Exclusion Criteria
* History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
* Smoked regularly in the past year
* Dietary restrictions substantially limiting compliance or vegetarian or Vegan diet
* Planning on changing diet or exercise behavior in the next 6 months
* Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
40 Years
70 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Terry Hartman
Terry Hartman PhD, MPH, RD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Terry J Hartman, PhD, MPH, RD
Role: PRINCIPAL_INVESTIGATOR
Rollins School of Public Health, Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Morehouse
Atlanta, Georgia, United States
Emory ACTSI
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00075830
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.