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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Casein glycomacropeptide (CGMP) | Active Comparator | During 4 weeks a daily oral intake of CGMP-protein-shake. |
|
| Placebo | Placebo Comparator | During 4 weeks a daily oral intake of placebo-shake consisting of milk powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casein glycomacropeptide | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with changes in systemic inflammation markers and cellular immune response | C-reactive protein, leukocyte count | 4 weeks |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik A Vilstrup, Professor | University of Aarhus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of medicine V (Hepatology and Gastroenterology) | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Dietary Supplement |
|
| 4 weeks |
| 4 weeks |