Casein Glycomacropeptide in Healthy Subjects

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02832700

Enrollment

Registered

2016-07-14

Start date

2016-06-30

Completion date

2017-09-01

Last updated

2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Disease

Keywords

glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome

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.

Interventions

DIETARY_SUPPLEMENTCasein glycomacropeptide

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Compliance	4 weeks	Number of participants with an average daily intake of above 75% of the intervention-product
Intestinal butyrate production	4 weeks	Number of participants with increase in daily butyrate-production

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026