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Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06495255
Enrollment
10
Registered
2024-07-10
Start date
2024-05-14
Completion date
2026-03-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

absorption, excretion, metabolic markers

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.

Interventions

DIETARY_SUPPLEMENTHuman Milk Oligosaccharides (HMOs)

HMOs will be applied as a neutral-flavoured powder

DIETARY_SUPPLEMENTControl

will be applied as powder

Sponsors

University Hospital, Bonn
CollaboratorOTHER
University of Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants are blinded to the supplement.

Intervention model description

Two or more interventions, each alone and in combination, are evaluated in parallel

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Absorption of HMOsthrough study completion, an average of 1 yearConcentration of HMOs in blood
Excretion of HMOsthrough study completion, an average of 1 yearConcentration of HMOs in urine

Secondary

MeasureTime frameDescription
Metabolismthrough study completion, an average of 1 yearConcentration of metabolic markers in blood

Countries

Germany

Contacts

Primary ContactMarie-Christine Simon, Jun. Prof.
mcsimon@uni-bonn.de+49 228 733814
Backup ContactSabrina Schenk, M.Sc.
sschenk@uni-bonn.de+ 49 228 734598

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026