HealthyNCT02716350
Effect of B-GOS on the Wellbeing and Ageing in Healthy 52-65 Years Old Individuals
A study testing B-GOS and Maltodextrin in people with Healthy, run by Clasado Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 52 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- B-GOS and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- B-GOS, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-GOSDietary supplement
Also called Bimuno
comparison versus placebo
MaltodextrinDietary supplement
Also called corn starch
placebo
| Study group | Role | What they receive |
|---|---|---|
| B-GOS | Experimental | powder, 3.5g/day Receives: Dietary Supplement: B-GOS |
| Maltodextrin | Placebo comparator | powder, 3.5g/day Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire as a measure of life quality
health related questions
Measured: 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
Measured: change from baseline CRP to 2, 4 (end of treatment) and 5 months (end of follow up)
Secondary outcomes (7)
α1-antitrypsin
α1-antitrypsin will be measured by Ortho Diagnostics analyser from blood
Measured: change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up)
blood pressure
Measured: 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: measured monthly for 5 months
questionnaire as a measure of mood
questions related to mood and sleep patterns
Measured: measured monthly for 5 months
lipids
lipids will be measured by Ortho Diagnostics analyser from blood
Measured: 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
Measured: 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
Measured: change from baseline length of telomeres to end of the treatment period (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clasado Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- General Hospital, States of Jersey
- Responsible party
- Sponsor
- Investigators
- Jelena Vulevic, phd, Study chair, Clasado Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716350
- Sponsor's protocol ID
- AGE2016
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02716350
- Acronym / sponsor ID
- AGE2016
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Clasado LimitedIndustry (pharma, biotech, devices)
- Collaborators
- General Hospital, States of Jersey
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-GOS | Experimental | Dietary Supplement: B-GOSpowder, 3.5g/day |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrinpowder, 3.5g/day |
Who may qualify
- Ages
- 52 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-GOSAlso: Bimunocomparison versus placebo | Dietary supplement | B-GOS |
| MaltodextrinAlso: corn starchplacebo | Dietary supplement | Maltodextrin |
Primary outcome
questionnaire as a measure of life quality
Time frame: change from baseline answers to 4 (end of treatment) and 5 months (end of follow up)
health related questions
C- reactive protein (CRP)
Time frame: change from baseline CRP to 2, 4 (end of treatment) and 5 months (end of follow up)
CRP will be measured by Ortho Diagnostics analyser from blood
7 secondary outcomes
α1-antitrypsin
Time frame: change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up)
blood pressure
Time frame: measured monthly for 5 months
questionnaire as a measure of bowel function
Time frame: measured monthly for 5 months
questionnaire as a measure of mood
Time frame: measured monthly for 5 months
lipids
Time frame: change from baseline lipids to 2, 4 (end of treatment) and 5 months (end of follow up)
glucose
Time frame: change from baseline glucose to 2, 4 (end of treatment) and 5 months (end of follow up)
telomere shortening
Time frame: change from baseline length of telomeres to end of the treatment period (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jelena Vulevic, phd study chair
Clasado Research Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-GOS and Maltodextrin in people with Healthy, run by Clasado Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire as a measure of life quality (time frame: change from baseline answers to 4 (end of treatment) and 5 months (end of follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.