Partial-enteral Nutrition Protocol for Crohn's Disease

NCT07113431 | Completed

• 1 other identifier: UMN2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease(CD)

Outcome Measures

Primary Outcomes (1)

• Nutrient intake

  Nutrient intake improvement assessed by 24-hour dietary recall from a combined intervention of a standard IBD-AID diet with an oral nutrition supplement drink (Kate Farms Peptide 1.5) compared to a standard diet alone without an oral nutrition supplement drink.

  8 weeks

Secondary Outcomes (1)

• Body composition

  8 weeks

Study Arms (2)

IBD-AID diet

PLACEBO COMPARATOR

Other: IBD-AID diet

IBD-AID Diet + Kate Farms Peptide 1.5

ACTIVE COMPARATOR

Dietary Supplement: IBD-AID diet combined with Kate Farms Peptide 1.5

Interventions

IBD-AID diet OTHER

Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)

IBD-AID diet

IBD-AID diet combined with Kate Farms Peptide 1.5 DIETARY_SUPPLEMENT

Combining standardized-IBD diet developed by the University of Minnesota (IBD-AID) with commercially available pea protein plant-based enteral nutrition formula (Kate Farms Peptide 1.5)

IBD-AID Diet + Kate Farms Peptide 1.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of short bowel syndrome
• Presence of ileostomy or colostomy
• Presence of a pacemaker or any electronic implantable device
• Use of pre or probiotic supplements within 14 days of randomization
• High risk for development of refeeding syndrome
• In the opinion of the investigator would not complete the study procedures
• Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices
• Pregnant Patients: while the use of bioimpedance technology in pregnant patients has been shown to have no adverse effects, it has yet to be clinically validated for use with that population group
• Serious, concomitant illness that, in the opinion of the investigator would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation

Sponsors & Collaborators

• Kate Farms Inc: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2023
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)