Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133530
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-15
First Post:
2023-09-25
Brief Title:
Human Milk Oligosaccharides HMOs and Gut Microbiota Immune System in Antarctica
Sponsor:
IU University of Applied Sciences
Organization:
IU University of Applied Sciences
Study Overview
Official Title:
Effects of Human Milk Oligosaccharides HMOs on Gut Microbiota Immune System and Metabolism in Adults Wintering Over in Antarctica
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 ie 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 eg pectins and non-digestible oligosaccharides eg 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 hosts 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 55 g of an HMO mixture during hibernation at Concordia Station in Antarctica affects
glucose tolerance
inflammatory processes
immune function
fat and bone metabolism and
Well-being
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 ie the treatment measure used in this study in one group is the daily administration of 55 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
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 eg pectins and non-digestible oligosaccharides eg 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 hosts 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 55 g of an HMO mixture during hibernation at Concordia Station in Antarctica affects
glucose tolerance
inflammatory processes
immune function
fat and bone metabolism and
Well-being
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 ie the treatment measure used in this study in one group is the daily administration of 55 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None