General Hospital Jersey
Saint Helier, Jersey, United Kingdom
NCT Number: NCT02716350
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.
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Notify Me52 year–65 year
All sexes
Interventional
Not applicable
Saint Helier, Jersey, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
comparison versus placebo
Other names: Bimuno
placebo
Other names: corn starch
Time frame: change from baseline answers to 4 (end of treatment) and 5 months (end of follow up)
health related questions
Time frame: change from baseline CRP to 2, 4 (end of treatment) and 5 months (end of follow up)
CRP will be measured by Ortho Diagnostics analyser from blood
Time frame: change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up)
α1-antitrypsin will be measured by Ortho Diagnostics analyser from blood
Time frame: measured monthly for 5 months
Time frame: measured monthly for 5 months
diary that includes 5-consecutive days of questions related to stool frequency and consistency
Time frame: measured monthly for 5 months
questions related to mood and sleep patterns
Time frame: change from baseline lipids to 2, 4 (end of treatment) and 5 months (end of follow up)
lipids will be measured by Ortho Diagnostics analyser from blood
Time frame: change from baseline glucose to 2, 4 (end of treatment) and 5 months (end of follow up)
glucose will be measured by Ortho Diagnostics analyser from blood
Time frame: change from baseline length of telomeres to end of the treatment period (4 months)
telomeres will be measured from peripheral blood mononuclear cells
Clasado Limited
Industry
A Double Blind, Placebo Controlled, Randomised, Single Centred, Parallel Study to Determine the Potential of B-GOS, to Beneficially Influence the Wellbeing and Ageing in Healthy 52-65 Years Old Individuals
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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