A Novel Partial-enteral Nutrition Protocol to Improve Nutrition Status of Adults Patients Experiencing a Crohn's Disease Flare and Starting New Immunologic Therapy.

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A novel dietary intervention combining a standardized IBD diet (IBD-AID) with supplementation from a pea protein plant-based oral nutrition supplement (ONS) (Kate Farms Peptide 1.5) to improve protein, calorie, and nutrient intake in adult patients experiencing a Crohn's disease flare starting new immunologic therapy. Additionally, this study will include objective measures of body composition to improve nutrition status assessment and provide a more sensitive measure of intervention efficacy compared to anthropometric measures of body weight or BMI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Moderate to severe CD as defined by physician and starting new biologic therapy

• Able and willing to complete the study procedures

• Age \> 18

• Able to comply with study measures in the opinion of the investigator

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Clinical Research Coordinator
chen8124@umn.edu
(612) 301-8294
Backup
Co-Investigator
teige027@umn.edu
612-301-1625
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 20
Treatments
Placebo_comparator: IBD-AID diet
Active_comparator: IBD-AID Diet + Kate Farms Peptide 1.5
Related Therapeutic Areas
Sponsors
Leads: Kate Farms Inc
Collaborators: University of Minnesota

This content was sourced from clinicaltrials.gov