Casein Glycomacropeptide in Healthy Subjects

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832700
• Other study ID #: CGMPH2016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: June 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Casein glycomacropeptide

• Placebo

Locations

Country	Name	City	State
Denmark	Department of medicine V (Hepatology and Gastroenterology)	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Arla Foods

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance	Number of participants with an average daily intake of above 75% of the intervention-product	4 weeks
Other	Intestinal butyrate production	Number of participants with increase in daily butyrate-production	4 weeks
Primary	Number of participants with changes in systemic inflammation markers and cellular immune response	C-reactive protein, leukocyte count	4 weeks
Secondary	Number of participants with changes in the intestinal microbiome	alfa- and beta-diversity	4 weeks
Secondary	Number of participants with changes in gastrointestinal symptoms	questionnaire	4 weeks