Casein Glycomacropeptide in Healthy Subjects

University of Aarhus24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastrointestinal Disease

Interventions

Casein glycomacropeptideDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, Denmark

Outcomes

Primary Outcomes

Number of participants with changes in systemic inflammation markers and cellular immune response

C-reactive protein, leukocyte count

Time frame: 4 weeks

Secondary Outcomes

Number of participants with changes in the intestinal microbiome

alfa- and beta-diversity

Time frame: 4 weeks

Number of participants with changes in gastrointestinal symptoms

questionnaire

Time frame: 4 weeks

Data from ClinicalTrials.gov

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