Crohn's Disease(CD)
Conditions
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.
Interventions
DIETARY_SUPPLEMENTIBD-AID diet combined with Kate Farms Peptide 1.5
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)
OTHERIBD-AID diet
Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID)
Sponsors
University of Minnesota
Kate Farms Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutrient intake | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 8 weeks | Body composition measures assessed by bioimpedance spectroscopy (BIS). |
Countries
United States
Outcome results
None listed