Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome

NCT05482464 | Completed

• 1 other identifier: IRB-2021-1186
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the use of glycomacropeptide (GMP) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (IBS).

Conditions

Inflammatory Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Measure the inflammatory markers in stool and blood using immunology multiplex assay

  Change in levels of inflammatory markers (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E/IL-25, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, MIP-3α/CCL20, TNF-α and TNFβ) in stool and blood using immunology multiplex assay

  Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3

• Stool sample based gut microbiome composition using 16S rRNA gene sequencing

  Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing.

  Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3

Study Arms (1)

Casein glycomacropeptide (CGMP)

OTHER

The subjects will receive a daily oral intake of CGMP-protein-shake for 3 weeks with a 1 week wash-in and a 3 week wash-out. Intervention: Dietary Supplement: Casein glycomacropeptide (CGMP)

Dietary Supplement: Casein glycomacropeptide (CGMP)

Interventions

Casein glycomacropeptide (CGMP) DIETARY_SUPPLEMENT

Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Casein glycomacropeptide (CGMP)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fluent in English
• IBS diagnosis with Rome IV criteria
• People who have a primary care provider

You may not qualify if:

• Lactose or milk protein intolerance
• Any known other gastrointestinal disease or disorder beyond IBS, or major gastrointestinal surgery
• Habitual use of laxatives or antacids
• Pregnant or nursing.
• Use of pre or probiotics within one month prior to the study
• Use of antibiotics within one month prior to the study

Sponsors & Collaborators

• Oregon State University: lead
• BUILD Dairy: collaborator
• Agropur: collaborator

Study Sites (1)

Milam Hall, Room 001

Corvallis, Oregon, 97331, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single group assignment

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)