Clinical trial NCT02716350: Effect of B-GOS on the Wellbeing and Ageing in Healthy 52-65 Years Old Individuals
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Clasado Limited
Sponsor class: INDUSTRY
Collaborators: name: General Hospital, States of Jersey
First posted: 2016-03-23
Enrollment: 63
Sex: ALL
Minimum age (years): 52
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: questionnaire as a measure of life quality
timeFrame: change from baseline answers to 4 (end of treatment) and 5 months (end of follow up)
measure: C- reactive protein (CRP)
timeFrame: change from baseline CRP to 2, 4 (end of treatment) and 5 months (end of follow up)
Secondary outcomes:
measure: α1-antitrypsin
timeFrame: change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up)
measure: blood pressure
timeFrame: measured monthly for 5 months
measure: questionnaire as a measure of bowel function
timeFrame: measured monthly for 5 months
measure: questionnaire as a measure of mood
timeFrame: measured monthly for 5 months
measure: lipids
timeFrame: change from baseline lipids to 2, 4 (end of treatment) and 5 months (end of follow up)
measure: glucose
timeFrame: change from baseline glucose to 2, 4 (end of treatment) and 5 months (end of follow up)
measure: telomere shortening
timeFrame: change from baseline length of telomeres to end of the treatment period (4 months)
Other outcomes:
Locations:
city: Saint Helier
country: United Kingdom
facility: General Hospital Jersey
state: Jersey
Study officials:
affiliation: Clasado Research Services
name: Jelena Vulevic, phd
role: STUDY_CHAIR
References: