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

NCT06133530 | Enrolling By Invitation

• 1 other identifier: PreGlu
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults; High Altitude; Isolation, Social

Keywords

Immune status; Isolation; High altitude; Glucose tolerance; Gut microbiota; Short chain fatty acids; Bone turnover markers

Outcome Measures

Primary Outcomes (2)

• Glucose tolerance

  Area under the serum glucose concentration curve (2 hours) over time

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Insulin resistance

  Area under the serum insulin concentration curve (2 hours) over time

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

Secondary Outcomes (12)

• Fecal calprotectin

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Fecal zonulin

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Fecal short chain fatty acids

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Gut microbiota profiling

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Saliva cortisol

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

Other Outcomes (18)

• Viral activation

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• Vitamin D status

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

• GABA and BDNF

  baseline, pre-Antarctica; every 1-2 month from month 4 to 10 during the stay in Antarctica (total stay about 12 month); about 6-7 month after return from Antarctica

Study Arms (2)

Maltose

PLACEBO COMPARATOR

The placebo contains maltose powder applied orally.

Dietary Supplement: Maltose

Human milk oligosaccahride

EXPERIMENTAL

The experimental group HMO powder applied orally.

Dietary Supplement: Human milk oligosaccharides

Interventions

Human milk oligosaccharides DIETARY_SUPPLEMENT

Prebiotic

Human milk oligosaccahride

Maltose DIETARY_SUPPLEMENT

Control

Maltose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Institute of Food Technologies: collaborator
• IU University of Applied Sciences: lead
• University of Bologna: collaborator
• University of Bonn: collaborator
• National Aeronautics and Space Administration (NASA): collaborator
• University of Lorraine: collaborator
• Chr Hansen: collaborator
• European Space Agency: collaborator
• MVZ Institute for Microecology: collaborator
• DLR German Aerospace Center: collaborator

Study Sites (1)

IU International University of Applied Sciences

Erfurt, 99084, Germany

Location

MeSH Terms

Conditions

Altitude Sickness; Social Isolation

Interventions

Maltose

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Martina Heer, PhD

  IU International University of Applied Sciences, Erfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Direction Nutritional Sciences

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: November 15, 2023
• Study Start: September 24, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-04

Locations

DE (1)