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Completed

NCT Number: NCT02832700

Casein Glycomacropeptide in Healthy Subjects

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.

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Key information

Conditions

Gastrointestinal Disease Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Casein glycomacropeptide

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

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

    Time frame: 4 weeks

    C-reactive protein, leukocyte count

Secondary outcomes

  1. Number of participants with changes in the intestinal microbiome

    Time frame: 4 weeks

    alfa- and beta-diversity

  2. Number of participants with changes in gastrointestinal symptoms

    Time frame: 4 weeks

    questionnaire

Other outcomes

  1. Compliance

    Time frame: 4 weeks

    Number of participants with an average daily intake of above 75% of the intervention-product

  2. Intestinal butyrate production

    Time frame: 4 weeks

    Number of participants with increase in daily butyrate-production

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Arla Foods

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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