An interventional study of Human milk oligosaccharides and Maltose in Healthy Adults, High Altitude and Isolation, Social, sponsored by IU University of Applied Sciences. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by IU University of Applied Sciences · Not applicable, Interventional, and Treatment
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
The aim of this study is to investigate the effect of supplementation with prebiotics, a specific mixture of carbohydrates found in breast milk (HMOs), as a measure to improve intestinal flora, inflammatory processes in the gut, general immune status, carbohydrate regulation, fat and bone metabolism and neurological changes in Antarctica. The approximately one-year stay at Concordia Station (Antarctica) at an altitude of about 3200 m includes a long journey and subsequent extreme environmental conditions as well as corresponding adaptation mechanisms and is therefore a very good terrestrial model (analogue model) for investigating changes during space stays. Long-term (i.e. > 6 months) exposure to microgravity leads to numerous physiological responses, including impaired glucose tolerance, reduced immune function and bone loss, which can lead to quite severe health consequences. In this analogue model, similar changes, albeit less severe, are observed with regard to the immune system or glucose tolerance as in space flight.
The composition of the diet significantly influences the composition of the intestinal flora. In particular, dietary carbohydrates provide the substrate for certain bacteria that could have a positive effect on health. Prebiotics are defined as substrates that are selectively used by host microorganisms and that provide health benefits. Prebiotics are digested only by gut microorganisms and stimulate the growth or activity of bacteria in the gut that have shown health benefits or improved well-being. The main nutrients for bacterial growth are non-digestible carbohydrates, which by definition are not digested by the host, in this case the human organism (host). Non-digestible carbohydrates include, for example, resistant starch and dextrins, non-starch polysaccharides (NSPs) (e.g. pectins) and non-digestible oligosaccharides (e.g. Raffinose, inulin, etc.). These carbohydrates are fermented by the intestinal bacteria to short-chain fatty acids (SCFAs), mainly acetic acid, propionic acid and butyric acid. This process takes place mainly in the large intestine, but also in the small intestine. SCFAs are rapidly absorbed by the mucosa of the large intestine and exert whole-body effects, contributing, for example, to the host's energy needs or mediating gut-brain communication, which has a major impact on the physiology and health of the host.
HMOs are also prebiotics and are the third most abundant solid component in breast milk. Most of the research published to date on the effects of HMOs has therefore been conducted on infants. HMOs are not digested in the intestine and are mainly utilised in the large intestine by the bacteria that reside there. In infants, it has been shown that HMOs not only promote a healthy composition of the intestinal flora, but also impair the growth of pathogens and modulate the expression of genes involved in inflammation. Several in vitro and in vivo studies have shown antiviral properties of HMOs against various viruses such as rotavirus, norovirus, HIV and influenza. HMOs play a significant role in the immune system by enhancing the immune response. Initial applications of HMOs in adults have supported these findings.
Therefore, this study aims to investigate how daily administration of 5.5 g of an HMO mixture during hibernation at Concordia Station in Antarctica affects:
Study procedure This is a so-called placebo-controlled, randomised intervention study in parallel design. This means that subjects will be randomly selected to receive either the mixture of HMOs daily or a placebo. The study duration for a test person is approx. 20 months. It is divided into an examination phase before departure to Antarctica, approximately in September of a year, six phases during the wintering in Antarctica and one phase approximately 6 months after return.
Each individual phase is identical, one example shown in Figure 1.
Day 1 (Weekend day) Day 2 Day 3 Day 4 Day 5 Fasting blood collection X Oral glucose tolerance-test X Saliva sample X Feces sample X X X (X) Diet log X X X HMO supplementation Daily, onset after first session at Concordia
Figure 1: Representation of each phase (U as in figure 1) of testing
Intervention The intervention, i.e. the treatment measure used in this study, in one group is the daily administration of 5.5 g of a carbohydrate mixture analogous to human milk but produced by bacteria. This amount is certified by the European Control Authority as safe for human consumption. The other group receives a corresponding placebo, Maltose.
Measurement method Blood test and venous access Blood sampling from the peripheral vein is associated with the usual risks of venipuncture. These are haematomas or infections at the puncture site. When a peripheral venous access is placed, in rare cases there may be injuries to the vein (sclerotherapy) and the peripheric nerves. Blood collection and venous access are performed by an experienced doctor, which minimises the risk.
Fasting blood collections Fasting blood samples for analysis of various blood parameters are taken on the same day as the oral glucose tolerance test (OGTT) (see figure 1). Since several blood samples are taken for the OGTT, also after the drink has been taken, a venous access in the form of an indwelling venous cannula (small plastic tube) will be placed in the area of the forearm in order to avoid repeated puncturing of the arm veins.
Glucose tolerance by means of an oral glucose tolerance test The so-called oral glucose tolerance test (OGTT) can be used to determine differences in glucose metabolism (sugar metabolism) between the intervention and control phases. On approximately day 3 of each study phase, a drink will be consumed in the morning, fasting state, which is prepared from 75 g glucose (Medicalfox Gluko 75 powder) and 300 ml drinking water. Blood is taken every 15 minutes in the first hour after the drink is given, and every 30 minutes in the second hour.
Saliva sample Saliva samples will be taken to test certain hormones that reflect stress levels, as well as the reactivity of certain viruses (herpes virus, rotavirus). For this purpose, a small cotton wool roll from a prepared container (salivette) is chewed in the mouth for several minutes and returned to the collection tube once during the examination phase. The saliva obtained is frozen and later analysed in the laboratory.
Faecal collection In order to examine the changes in the intestinal flora, faeces samples are taken on 3 consecutive days in each phase. For this purpose, a so-called 'Feces Catcher' is placed over the toilet to better collect the faeces. Three samples are then taken from these faeces in 3 different tubes. The small spoon in each tube is filled with faeces, put back into the tube, closed and frozen.
Documentation of the diet In order to be able to estimate the influence of the food composition on the intestinal flora, the food consumed is documented on 2 working days and one weekend day. This is done in a prepared dietlog.
216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.
This study's planned enrollment of 26 is below the median of 34 across 178 interventional studies indexed under Altitude Sickness.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The placebo contains maltose powder applied orally.
Dietary Supplement: Maltose
The experimental group HMO powder applied orally.
Dietary Supplement: Human milk oligosaccharides
Prebiotic
Control
Glucose tolerance
Area under the serum glucose concentration curve (2 hours) over time
Time frame: 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
Time frame: 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 calprotectin
Concentration changes in feces (µg/g) over time
Time frame: 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
Concentration changes in feces (ng/ml) over time
Time frame: 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
Concentration changes in feces (mmol/l) over time
Time frame: 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
Feces feces will be analyzed for microbiota composition by 16S rRNA gene-based next-generation sequencing; Alpha and beta diversity, taxonomic assignment and relative abundance of bacterial groups will be characterized by bioinformatics.
Time frame: 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
Cortisol concentration changes in saliva over time
Time frame: 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 DHEA
DHEA concentration changes in saliva over time
Time frame: 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
Inflammation markers in blood
Changes in blood cytokines concentration (EGF, FGF-2, Eotaxin, TGF-α, G-CSF, Flt-3L, GM-CSF, Fractalkine, IFNa2, IFNy, GRO, IL-10, MCP-3), IL-12P40, MDC, IL-12P70, IL-13, IL-15, sCD40L, IL-17, IL-1RA, IL-1α, IL-9, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IP-10, MCP-1, MIP-1α, MIP-1β, TNFα, TNFβ, VEGF, PDGF-AA, PDGFAB-BB, RANTES) pg/ml changes over time
Time frame: 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
CRP changes in blood
Changes (mg/L) in blood C-reactive protein concentrations over time
Time frame: 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
Lipid metabolism
Serum concentration changes of triglycerides, total-, HDL-, LDL-cholesterol over time
Time frame: 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
Glycated albumin
Serum concentration changes of blood glycated albumin over time in g/l and %
Time frame: 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
GLP-1
Serum concentration changes of GLP-1 (pmol/l) over time
Time frame: 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
Fetuin-A
Serum concentration changes of Fetuin-A (µg/ml) over time
Time frame: 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
Viral activation
Latent herpes virus shedding changes over time
Time frame: 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
Serum concentration changes of 25-OH and 1,25 OH vitamin D over time
Time frame: 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
Changes in serum concentrations of GABA and BDNF (pg/ml) over time
Time frame: 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
Serotonin in blood
Changes in serum concentrations of serotonin (ng/ml) over time
Time frame: 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
Kynurenine in blood
Changes in serum concentrations of Kynurenine (µmol/l) over time
Time frame: 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
Changes in further tryptophan metabolites
Changes in serum concentrations of Kynurenic acid, Quinolinic acid, Picolinic acid, Methylnicotinamide, Quinaldic acid, 3-hydroxykynurenine, Anthranilic acid, Nicotinamide (nmol/l) over time
Time frame: 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
Bone formation marker
Changes in serum concentrations of PINP in µg/L
Time frame: 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
Bone resorption marker
Changes in serum concentrations of ß-CTX in ng/L
Time frame: 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
Body weight
Changes in body weight (kg) over time
Time frame: 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
Body height
Measurement of body height to derive changes in body mass index
Time frame: pre-Antarctica
Profile of mood states
The profile of mood states is a psychological rating scale to measure changes in six different dimensions of mood (tension, depression, anger, vigour, fatigue, confusion) measured by a questionnaire. It is a five point scale ranging from "not at all" to "extremely".
Time frame: 5 consecutive days at baseline, pre-Antarctica; 5 consecutive days every month during the 12 month stay at Antarctica; 5 consecutive days 6-7 month after return from Antarctica
Positive and negative affect schedule
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Time frame: 5 consecutive days at baseline, pre-Antarctica; 5 consecutive days every month during the 12 month stay at Antarctica; 5 consecutive days 6-7 month after return from Antarctica
Appraisal of life events scale
The Appraisal of life events scale (ALE) measures three factors of appraisal: threat, challenge and loss. It is an adjective check list of 16 adjectives rated on a 6-point scale (1 = disagree very strongly, 6= agree very strongly) that can be used to assess appraisals of retrospectively recalled stressful events as well as ongoing stressful encounters.
Time frame: baseline, pre-Antarctica; about 6-7 month after return from Antarctica
Subjective assessment of performance by a Visual Analogue Scale
The subjective Assessment of Performance Visual Analogue Scale measures factors such as stress, pain, and anxiety using a visual analog scale. The scale is a numerical rating scale ranking the respective factors from 1 to 10. A higher score indicates greater intensity of the respective factor.
Time frame: baseline, pre-Antarctica; every month during the 12 month stay at Antarctica; about 6-7 month after return from Antarctica
General health Questionnaire (GHQ)
The General health Questionnaire (GHQ) focuses on two major areas - the inability to carry out normal functions and the appearance of new and distressing phenomena. It is a 28 item questionnaire and assesses the respondent's current state and asks if that differs from his or her usual state. Each item is accompanied by four possible responses, typically being 'not at all', 'no more than usual', 'rather more than usual' and 'much more than usual', scoring from 0 to 3, respectively.
Time frame: baseline, pre-Antarctica; every month during the 12 month stay at Antarctica; about 6-7 month after return from Antarctica
Global Physical Activity Questionnaire
The Global Physical Activity Questionnaire (GPAQ) comprises 19 questions grouped to capture physical activity undertaken in different behavioral domains: work, transport, discretionary and time spent in sedentary activities. It asks for whether at all and if, how many days and how long the respective activity will usually be carried out.
Time frame: baseline, pre-Antarctica
Depression symptoms
Center for Epidemiologic Studies Depression Scale is a 20-item measure that asks the test subjects to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time frame: Mid-term of the 12 month stay in Antarctica
Nutrient intake
Food frequency questionnaire measuring food habits and dietary intake during 3 consecutive days including one weekend day.
Time frame: 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
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Studies of the drug tested here: Human milk oligosaccharides