Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06032104
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-08-24
Brief Title:
Feasibility and Colorectal Benefits of Pulses Supplementation
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Feasibility of Pulses Supplementation in Healthy Adults A Feeding Study
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Beans are a forgotten staple food that shows promise in improving health The goal of this study is to look at how bean supplementation affects metabolic and bowel health In the long-term the investigators believe this research will lead to a better understanding of the impact of beans on bowel health The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future
Detailed Description:
Investigators are seeking adults planning for a standard of care colonoscopies part of the participants usual care As part of this feeding study a participant will be randomly assigned to either two weeks of a dry bean smoothie that the investigators will provide in addition to the participants usual diet or continue with participants usual diet without the bean smoothie including the food and drink guidelines for the colonoscopy 2 weeks before or after the participant colonoscopy
Participants involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy each research visit will be 30-60 minutes in length scheduled close to 2-4 weeks prior to the colonoscopy day of the colonoscopy as well as 2-12 weeks after the colonoscopy depending on participant availability The investigators expect about 25 people aged 35-75 to participate in this research
Participation in this study will involve collecting breath tests fecal stool samples 8 Teaspoons of blood clinical data and participant questionnaire data At the time of colonoscopy the investigators will also sample the mucosa lining of the bowel and remnant leftover or discarded tissue from an intestine biopsy obtained as part of the participants clinical care Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participants medical records This information will become part of the research data
Participants involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy each research visit will be 30-60 minutes in length scheduled close to 2-4 weeks prior to the colonoscopy day of the colonoscopy as well as 2-12 weeks after the colonoscopy depending on participant availability The investigators expect about 25 people aged 35-75 to participate in this research
Participation in this study will involve collecting breath tests fecal stool samples 8 Teaspoons of blood clinical data and participant questionnaire data At the time of colonoscopy the investigators will also sample the mucosa lining of the bowel and remnant leftover or discarded tissue from an intestine biopsy obtained as part of the participants clinical care Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participants medical records This information will become part of the research data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None