Bioavailability of Human Milk Oligosaccharides in Healthy Adults

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Bonn

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age: 18-40 Years

Non-smoker

Normal weight (BMI 18.5-25.0 kg/m²)

Disqualifiers

Impaired insulin sensitivity/glucose tolerance

Underweight or overweight/obesity

Regular intake of nutritional supplements

Alcohol, drug or medication abuse

Trial design

Design model

Factorial

Treatments tested in this trial

  • Human Milk Oligosaccharides (HMOs)

    Dietary supplement

    HMOs will be applied as a neutral-flavoured powder

  • Control

    Dietary supplement

    will be applied as powder

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absorption of HMOs

Concentration of HMOs in blood

Time frame
through study completion, an average of 1 year
2

Excretion of HMOs

Concentration of HMOs in urine

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Metabolism

Concentration of metabolic markers in blood

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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University of Bonn

Lead sponsor

University Hospital, Bonn

Collaborator