Clinical Trials Directory

Trials / Completed

CompletedNCT04598529

Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients

Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in Irritable Bowel Syndrome Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This aim of this study is to evaluate the acute and mid-term effects of A2 milk versus conventional milk on gastrointestinal symptoms in patients with constipation-predominant IBS and in patients with diarrhea-predominant IBS. Moreover, the effect of immune and defense markers will be studied.

Detailed description

Irritable bowel syndrome (IBS) is a prevalent functional bowel disorder in which recurrent abdominal pain is associated with defecation and altered bowel habits. Although the pathophysiology is incompletely understood, it is generally regarded as a multifactorial disorder involving host factors such as low-grade immune activation, altered intestinal barrier function and defense. Environmental factors, including diet, are also suggested to play a role. Dairy products such as cow's milk are widely produced and an important component of the human diet. Cow's milk is composed of various macronutrients, micronutrients and water. Beta-casein is a major protein component of cow's milk; most cows produce a mixture of A1 and A2 beta-casein (conventional milk), whereas some cows produce only A2 beta-casein (A2 milk). It has been suggested that specific components in cow's milk, such as A1 beta-casein, may trigger gastrointestinal symptoms after intake. The purpose of this randomized, double-blind, cross-over study performed in Maastricht University Medical Center (MUMC+) is to explore the acute and mid-terms effects of A2 milk versus conventional milk on gastrointestinal symptoms and immune and defense markers in separate groups of patient with constipation-predominant IBS and in patients with diarrhea-predominant IBS.

Conditions

Interventions

TypeNameDescription
OTHERA2 milka variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).
OTHERConventional milkcow's milk with a mixture of A1 and A2 beta-casein.

Timeline

Start date
2022-08-08
Primary completion
2023-06-05
Completion
2023-06-05
First posted
2020-10-22
Last updated
2024-01-05

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04598529. Inclusion in this directory is not an endorsement.