Effect of B-GOS on the Wellbeing and Ageing in Healthy 52-65 Years Old Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: B-GOS
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 52 and 65 years of age In good general health, defined as no comorbidities requiring regular medical follow up Ability to communicate well with the investigator and to comply with the requirements of the entire study The volunteer has given written informed consent to participate and is willing to participate in the entire study Exclusion Criteria: History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks and during the trial period Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study Undergone surgical resection of any part of the bowel History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma). Currently prescribed immunosuppressive drugs Intention to use regularly other medication which affects gastrointestinal motility and/or perception Current or recent history (within 12 months) of significant drug or alcohol abuse or dependence

Ages Eligible for Study
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Minimum Age: 52 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-GOS<br>powder, 3.5g/day | Dietary Supplement: B-GOS<br>* comparison versus placebo<br>* Other names: Bimuno;|
| Placebo Comparator: Maltodextrin<br>powder, 3.5g/day | Dietary Supplement: Maltodextrin<br>* placebo<br>* Other names: corn starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) |