Clinical trial NCT06495255: Bioavailability of Human Milk Oligosaccharides in Healthy Adults
Official title: Bioavailability of Human Milk Oligosaccharides in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: absorption
excretion
metabolic markers
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: University Hospital, Bonn
First posted: 2024-07-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two or more interventions, each alone and in combination, are evaluated in parallel
Primary purpose: BASIC_SCIENCE

Brief summary: Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a "balanced" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Age: 18-40 Years
* Non-smoker
* Normal weight (BMI 18.5-25.0 kg/m²)

Exclusion Criteria:

* Impaired insulin sensitivity/glucose tolerance
* Underweight or overweight/obesity
* Regular intake of nutritional supplements
* Alcohol, drug or medication abuse
* Pregnancy and breastfeeding
* Hypo- and hypertension
* Epilepsy
* known hepatitis B, hepatitis C, HIV infection
* Malabsorption and maldigestion syndrome
* Type 1 or type 2 diabetes mellitus
* Other metabolic diseases
* Chronic inflammatory diseases
* Other chronic diseases
* Psychiatric illnesses
* Participation in another study

Primary outcomes:
measure: Absorption of HMOs
timeFrame: through study completion, an average of 1 year
measure: Excretion of HMOs
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Metabolism
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Rheinische Friedrich-Wilhelms Universität Bonn
Study officials:
References: