Casein Glycomacropeptide in Healthy Subjects
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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