Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Participants are blinded to the supplement.

Study Groups

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Intervention

HMO bolus administration

Group Type EXPERIMENTAL

Human Milk Oligosaccharides (HMOs)

Intervention Type DIETARY_SUPPLEMENT

HMOs will be applied as a neutral-flavoured powder

Control

bolus administration

Group Type EXPERIMENTAL

Control

Intervention Type DIETARY_SUPPLEMENT

will be applied as powder

Interventions

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Human Milk Oligosaccharides (HMOs)

HMOs will be applied as a neutral-flavoured powder

Intervention Type DIETARY_SUPPLEMENT

Control

will be applied as powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes