Casein Glycomacropeptide in Healthy Subjects

Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

The investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Casein glycomacropeptide

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Department of medicine V (Hepatology and Gastroenterology)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Caucasians
• Body Mass Index 18.5-25.0

Exclusion Criteria:

• Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
• Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
• Pregnant or nursing.
• Unable to speak and understand Danish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Casein glycomacropeptide (CGMP); During 4 weeks a daily oral intake of CGMP-protein-shake.	Dietary supplement: Casein glycomacropeptide
Placebo Comparator: Placebo; During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with changes in systemic inflammation markers and cellular immune response	C-reactive protein, leukocyte count	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with changes in the intestinal microbiome	alfa- and beta-diversity	4 weeks
Number of participants with changes in gastrointestinal symptoms	questionnaire	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Number of participants with an average daily intake of above 75% of the intervention-product	4 weeks
Intestinal butyrate production	Number of participants with increase in daily butyrate-production	4 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Arla Foods

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: whey protein; dietary proteins; human microbiome; glycopeptides; caseinomacropeptide; antiinflammatories
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: CGMPH2016