Bioavailability of Human Milk Oligosaccharides in Healthy Adults

NCT06495255 | Recruiting

• 1 other identifier: 299/22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

absorption; excretion; metabolic markers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Metabolism

  through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

HMO bolus administration

Dietary Supplement: Human Milk Oligosaccharides (HMOs)

Control

EXPERIMENTAL

bolus administration

Dietary Supplement: Control

Interventions

Human Milk Oligosaccharides (HMOs) DIETARY_SUPPLEMENT

HMOs will be applied as a neutral-flavoured powder

Intervention

Control DIETARY_SUPPLEMENT

will be applied as powder

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40 Years
• Non-smoker
• Normal weight (BMI 18.5-25.0 kg/m²)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead
• University Hospital, Bonn: collaborator

Study Sites (1)

Rheinische Friedrich-Wilhelms Universität Bonn

Bonn, 53115, Germany

RECRUITING

Central Study Contacts

Marie-Christine Simon, Jun. Prof.

CONTACT

+49 228 733814; mcsimon@uni-bonn.de

Sabrina Schenk, M.Sc.

CONTACT

+ 49 228 734598; sschenk@uni-bonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the supplement.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jun. Prof. Dr. Marie-Christine Simon (PI)

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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: July 10, 2024
• Study Start: May 14, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)