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| Name | Class |
|---|---|
| General Hospital, States of Jersey | UNKNOWN |
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To investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in healthy adults (52-65 years old). The study will consist of a 4 month randomised double blind parallel treatment period with either B-GOS of Placebo, and 1 month follow up period without treatments.
With age, several important alterations occur within the gastrointestinal (GI) tract, that are responsible for altered microbial environment (e.g. reduced diversity and number of beneficial bifidobacteria and higher populations of enterobacteria and clostridia).
Research over the past two decades has provided evidence that administration of probiotics (live microorganisms which, when administered in adequate amounts, confer a health benefit on the host) could be used to optimise gut microbiota and prevent and treat a range of diseases, as well as enhance immune function. Somewhat less documented and more recent concept is the use of prebiotics (nondigestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one, or a limited number of bacteria in the colon). Prebiotics are naturally available in breast milk and in certain vegetables but can also be synthetic oligosaccharides of which the best known and the most researched examples include fructooligosaccharides (FOS) and galactooligosaccharides (GOS). B-GOS is a low molecular weight GOS mixture, shown to increase the number of probiotic bacteria, especially bifidobacteria, in younger and older adults, irritable-bowel sufferers and overweight adults. B-GOS also significantly decreases the colonisation and pathology of salmonellosis and incidence and duration of traveller's diarrhoea.
Our aim is to investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in healthy adults (52-65 years old). The assessment would consist of various questionnaires covering quality of life, bowel function, mood and sleep and blood markers of inflammation and ageing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-GOS | Experimental | powder, 3.5g/day |
|
| Maltodextrin | Placebo Comparator | powder, 3.5g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-GOS | Dietary Supplement | comparison versus placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| questionnaire as a measure of life quality | health related questions | change from baseline answers to 4 (end of treatment) and 5 months (end of follow up) |
| C- reactive protein (CRP) | CRP will be measured by Ortho Diagnostics analyser from blood | change from baseline CRP to 2, 4 (end of treatment) and 5 months (end of follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| α1-antitrypsin | α1-antitrypsin will be measured by Ortho Diagnostics analyser from blood | change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up) |
| blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jelena Vulevic, phd | Clasado Research Services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Jersey | Saint Helier | Jersey | United Kingdom |
once the study is competed, codes will be unblinded and participants can receive their individual data upon written request - this is all listed in their information leaflets
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Maltodextrin | Dietary Supplement | placebo |
|
|
| measured monthly for 5 months |
| questionnaire as a measure of bowel function | diary that includes 5-consecutive days of questions related to stool frequency and consistency | measured monthly for 5 months |
| questionnaire as a measure of mood | questions related to mood and sleep patterns | measured monthly for 5 months |
| lipids | lipids will be measured by Ortho Diagnostics analyser from blood | change from baseline lipids to 2, 4 (end of treatment) and 5 months (end of follow up) |
| glucose | glucose will be measured by Ortho Diagnostics analyser from blood | change from baseline glucose to 2, 4 (end of treatment) and 5 months (end of follow up) |
| telomere shortening | telomeres will be measured from peripheral blood mononuclear cells | change from baseline length of telomeres to end of the treatment period (4 months) |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |