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

NCT ID: NCT02716350

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-07-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

B-GOS

powder, 3.5g/day

Group Type: EXPERIMENTAL

B-GOS

Intervention Type: DIETARY_SUPPLEMENT

comparison versus placebo

Maltodextrin

powder, 3.5g/day

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

B-GOS

comparison versus placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bimuno; corn starch

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

• Minimum Eligible Age: 52 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital, States of Jersey

UNKNOWN

Sponsor Role: collaborator

Clasado Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jelena Vulevic, phd

Role: STUDY_CHAIR

Clasado Research Services

Locations

General Hospital Jersey

Saint Helier, Jersey, United Kingdom

Countries

United Kingdom

Other Identifiers

AGE2016

Identifier Type: -

Identifier Source: org_study_id