Casein Glycomacropeptide in Healthy Subjects

NCT ID: NCT02832700

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Casein glycomacropeptide (CGMP)

During 4 weeks a daily oral intake of CGMP-protein-shake.

Group Type ACTIVE_COMPARATOR

Casein glycomacropeptide

Intervention Type DIETARY_SUPPLEMENT

Placebo

During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Casein glycomacropeptide

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hendrik A Vilstrup, Professor

Role: STUDY_CHAIR

University of Aarhus

Locations

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Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CGMPH2016

Identifier Type: -

Identifier Source: org_study_id

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