Bioavailability of Human Milk Oligosaccharides in Healthy Adults

July 2, 2024 updated by: Marie-Christine Simon, PhD MSc RD, University of Bonn
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marie-Christine Simon, Jun. Prof.
  • Phone Number: +49 228 733814
  • Email: mcsimon@uni-bonn.de

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: through study completion, an average of 1 year
Concentration of HMOs in blood
through study completion, an average of 1 year
Excretion of HMOs
Time Frame: through study completion, an average of 1 year
Concentration of HMOs in urine
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bonn

Collaborators

University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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