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Clinical Trials in Germany / NCT06133530
Enrolling by invitation Not applicable

Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica

NCT06133530 · tracked via the Priya Life Science Germany tracker
Sponsor
IU University of Applied Sciences
Phase
Not applicable
Started
2023-09-24
Last updated
2026-03-31

Condition(s) studied

Healthy AdultsHigh AltitudeIsolation, Social

Investigational drug(s) / intervention(s)

Human milk oligosaccharidesMaltose

Human milk oligosaccharides: Prebiotic

Maltose: Control

Study summary

Human milk oligosaccharides (HMOs) are the third-most abundant component in mothers' milk and are an important prebiotic factor for the development of the gut microbiota of infants, promoting the growth of certain beneficial bacterial strains and providing protection against many bacterial and viral infections. HMOs induce immunomodulatory activity by affecting immune cell populations and functions. In a simulator of the adult human intestinal microbial ecosystem, fermentation of HMOs led to an increase of bifidobacteria in parallel with an increase in short-chain fatty acids as well as a reduction in inflammation markers, supporting the potential of HMOs to provide health benefits also in adults. Long-term stay in microgravity induces many physiological responses, including diminished immune function and impaired glucose tolerance which may lead to rather severe consequences. Similarly, hypoxia conditions as in the Concordia station, affects the immune system and may lead to impaired glucose tolerance and insulin resistance. The hypothesis is that HMOs as a prebiotic supplement will mitigate changes in immune function, glucose tolerance, lipid homeostasis, and neurotransmitter production. It is expected that HMO supplementation will

* Modulate gut microbiota composition and function
* Improve inflammation status
* Improve immune function
* Improve glucose tolerance
* Improve nutritional status
* Prevent changes in neurotransmitters associated with anxiety and depression. During the stay in Antarctica an HMO blend will be supplemented to the verum group of volunteers. The control group will receive a placebo. Experiment days with blood drawing, an oral glucose tolerance test, saliva sampling, and feces samples are planned once before, about every second month in Concordia, and once after return.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Physically and mentally healthy subjects * Volunteers that are able and declare their willingness to participate in the entire study * Fasting blood glucose concentration: \<120 mg/dL * Willing to be assigned randomly either to the treatment or the control group * Successfully pass the medical screening * Signed informed consent * Social insurance Exclusion Criteria: * Medication that may interfere with the interpretation of the results * Recent sub-standard nutritional status * Abuse of drugs, medicine or alcohol * Participation in another study up to two months before study onset * Cannot clear a criminal background check * No signed consent form before the onset of the experiment * Blood donors in the past three months before the onset of the experiment * Vegetarian and Vegans

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IU International University of Applied Sciences Erfurt Germany
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06133530 on ClinicalTrials.gov ↗ ← All trials in Germany