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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Human Milk Oligosaccharides (HMOs); Dietary supplement: Control

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Christine Simon, Jun. Prof.; Phone Number: +49 228 733814; Email: mcsimon@uni-bonn.de
• Study Contact Backup: Name: Sabrina Schenk, M.Sc.; Phone Number: + 49 228 734598; Email: sschenk@uni-bonn.de

Study Locations

• Germany
  • Bonn, Germany, 53115
    • Recruiting
    • Rheinische Friedrich-Wilhelms Universität Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; HMO bolus administration	Dietary supplement: Human Milk Oligosaccharides (HMOs); HMOs will be applied as a neutral-flavoured powder
Experimental: Control; bolus administration	Dietary supplement: Control; will be applied as powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption of HMOs	Concentration of HMOs in blood	through study completion, an average of 1 year
Excretion of HMOs	Concentration of HMOs in urine	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolism	Concentration of metabolic markers in blood	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: absorption; excretion; metabolic markers
• Other Study ID Numbers: 299/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No