Casein Glycomacropeptide in Healthy Subjects
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJune 10, 2019
June 1, 2016
1.3 years
June 30, 2016
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with changes in systemic inflammation markers and cellular immune response
C-reactive protein, leukocyte count
4 weeks
Secondary Outcomes (2)
Number of participants with changes in the intestinal microbiome
4 weeks
Number of participants with changes in gastrointestinal symptoms
4 weeks
Other Outcomes (2)
Compliance
4 weeks
Intestinal butyrate production
4 weeks
Study Arms (2)
Casein glycomacropeptide (CGMP)
ACTIVE COMPARATORDuring 4 weeks a daily oral intake of CGMP-protein-shake.
Placebo
PLACEBO COMPARATORDuring 4 weeks a daily oral intake of placebo-shake consisting of milk powder.
Interventions
Eligibility Criteria
You may qualify if:
- Caucasians
- Body Mass Index 18.5-25.0
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Arla Foodscollaborator
Study Sites (1)
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hendrik A Vilstrup, Professor
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 14, 2016
Study Start
June 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
June 10, 2019
Record last verified: 2016-06