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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: B-GOS; Dietary supplement: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Jersey
    • Saint Helier, Jersey, United Kingdom
      • General Hospital Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B-GOS; powder, 3.5g/day	Dietary supplement: B-GOS; comparison versus placebo; Other Names: Bimuno
Placebo Comparator: Maltodextrin; powder, 3.5g/day	Dietary supplement: Maltodextrin; placebo; Other Names: corn starch

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Clasado Limited
• Collaborators: General Hospital, States of Jersey
• Investigators: Study Chair: Jelena Vulevic, phd, Clasado Research Services

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AGE2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: once the study is competed, codes will be unblinded and participants can receive their individual data upon written request - this is all listed in their information leaflets