Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Human Milk Oligosaccharides (HMOs); Dietary Supplement: Control

• Registration Number: NCT06495255
• Lead Sponsor: University of Bonn

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Study First Submitted: 2024-05-14
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Human Milk Oligosaccharides (HMOs)	HMO bolus administration
Control	Control	bolus administration

Primary Outcome Measures

Name	Time	Method
Absorption of HMOs	through study completion, an average of 1 year	Concentration of HMOs in blood
Excretion of HMOs	through study completion, an average of 1 year	Concentration of HMOs in urine

Secondary Outcome Measures

Name	Time	Method
Metabolism	through study completion, an average of 1 year	Concentration of metabolic markers in blood

Trial Locations

Locations (1)

Rheinische Friedrich-Wilhelms Universität Bonn; 🇩🇪 Bonn, Germany