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

Clasado

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: B-GOS

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02716350

AGE2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment

63 patients

Sex

All

Ages

52 to 65 years old

Volunteers

Accepts Healthy Volunteers

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