Casein Glycomacropeptide in Healthy Subjects

Not Applicable

Completed

• Conditions: Gastrointestinal Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Casein glycomacropeptide

• Registration Number: NCT02832700
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Caucasians
• Body Mass Index 18.5-25.0

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.
Casein glycomacropeptide (CGMP)	Casein glycomacropeptide	During 4 weeks a daily oral intake of CGMP-protein-shake.

Primary Outcome Measures

Name	Time	Method
Number of participants with changes in systemic inflammation markers and cellular immune response	4 weeks	C-reactive protein, leukocyte count

Secondary Outcome Measures

Name	Time	Method
Number of participants with changes in the intestinal microbiome	4 weeks	alfa- and beta-diversity
Number of participants with changes in gastrointestinal symptoms	4 weeks	questionnaire

Trial Locations

Locations (1)

Department of medicine V (Hepatology and Gastroenterology); 🇩🇰 Aarhus C, Denmark