Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT06495255

Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Led by University of Bonn · Updated on 2024-07-10

10

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

Sponsors

U

University of Bonn

Lead Sponsor

U

University Hospital, Bonn

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 40 years
  • Non-smoker
  • Normal weight with body mass index (BMI) between 18.5 and 25.0 kg/m2
Not Eligible

You will not qualify if you...

  • Impaired insulin sensitivity or glucose tolerance
  • Underweight or overweight/obesity
  • Regular intake of nutritional supplements
  • Abuse of alcohol, drugs, or medication
  • Pregnancy or breastfeeding
  • Low or high blood pressure (hypo- and hypertension)
  • Epilepsy
  • Known infections such as hepatitis B, hepatitis C, or HIV
  • Malabsorption or maldigestion syndromes
  • Type 1 or type 2 diabetes mellitus
  • Other metabolic diseases
  • Chronic inflammatory diseases
  • Other chronic diseases
  • Psychiatric illnesses
  • Participation in another clinical study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rheinische Friedrich-Wilhelms Universität Bonn

Bonn, Germany, 53115

Actively Recruiting

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Research Team

M

Marie-Christine Simon, Jun. Prof.

CONTACT

S

Sabrina Schenk, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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