Casein Glycomacropeptide in Healthy Subjects

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Disease

Intervention / Treatment
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* Dietary Supplement: Casein glycomacropeptide
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome