Gastrointestinal DiseaseNCT02832700
Casein Glycomacropeptide in Healthy Subjects
A study testing Casein glycomacropeptide in people with Gastrointestinal Disease, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- Casein glycomacropeptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasians
- Body Mass Index 18.5-25.0
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, 8000
About this study
Official title: Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects
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.
- Conditions
- Gastrointestinal Disease
- Being tested
- Casein glycomacropeptide, Placebo
- Keywords
- glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein glycomacropeptideDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Active comparator | During 4 weeks a daily oral intake of CGMP-protein-shake. Receives: Dietary Supplement: Casein glycomacropeptide |
| Placebo | Placebo comparator | During 4 weeks a daily oral intake of placebo-shake consisting of milk powder. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with changes in systemic inflammation markers and cellular immune response
C-reactive protein, leukocyte count
Measured: 4 weeks
Secondary outcomes (2)
Number of participants with changes in the intestinal microbiome
alfa- and beta-diversity
Measured: 4 weeks
Number of participants with changes in gastrointestinal symptoms
questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Sponsor
- Investigators
- Hendrik A Vilstrup, Professor, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832700
- Sponsor's protocol ID
- CGMPH2016
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects
- ClinicalTrials.gov ID
- NCT02832700
- Acronym / sponsor ID
- CGMPH2016
- Conditions
- Gastrointestinal Disease
- Keywords
- glycopeptides, dietary proteins, whey protein, caseinomacropeptide, antiinflammatories, human microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Jun 2016
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Active comparator | Dietary Supplement: Casein glycomacropeptideDuring 4 weeks a daily oral intake of CGMP-protein-shake. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDuring 4 weeks a daily oral intake of placebo-shake consisting of milk powder. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Caucasians
- Body Mass Index 18.5-25.0
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casein glycomacropeptide | Dietary supplement | Casein glycomacropeptide (CGMP) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Number of participants with changes in systemic inflammation markers and cellular immune response
Time frame: 4 weeks
C-reactive protein, leukocyte count
2 secondary outcomes
Number of participants with changes in the intestinal microbiome
Time frame: 4 weeks
Number of participants with changes in gastrointestinal symptoms
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik A Vilstrup, Professor study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein glycomacropeptide in people with Gastrointestinal Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with changes in systemic inflammation markers and cellular immune response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.