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NCT Number: NCT06495255

Bioavailability of Human Milk Oligosaccharides in Healthy Adults

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheinische Friedrich-Wilhelms Universität Bonn

Bonn, 53115, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Milk Oligosaccharides (HMOs)

Dietary Supplement

HMOs will be applied as a neutral-flavoured powder

Control

Dietary Supplement

will be applied as powder

Primary outcomes

  1. Absorption of HMOs

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

    Concentration of HMOs in blood

  2. Excretion of HMOs

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

    Concentration of HMOs in urine

Secondary outcomes

  1. Metabolism

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

    Concentration of metabolic markers in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Christine Simon, Jun. Prof.

CONTACT

[email protected]

+49 228 733814

Sabrina Schenk, M.Sc.

CONTACT

[email protected]

+ 49 228 734598

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • University Hospital, Bonn

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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