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Completed

NCT Number: NCT02716350

Effect of B-GOS on 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.

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Key information

Conditions

Age range

52 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital Jersey

Saint Helier, Jersey, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-GOS

Dietary Supplement

comparison versus placebo

Other names: Bimuno

Maltodextrin

Dietary Supplement

placebo

Other names: corn starch

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. α1-antitrypsin

    Time frame: change from baseline α1-antitrypsin to 2, 4 (end of treatment) and 5 months (end of follow up)

    α1-antitrypsin will be measured by Ortho Diagnostics analyser from blood

  2. blood pressure

    Time frame: measured monthly for 5 months

  3. questionnaire as a measure of bowel function

    Time frame: measured monthly for 5 months

    diary that includes 5-consecutive days of questions related to stool frequency and consistency

  4. questionnaire as a measure of mood

    Time frame: measured monthly for 5 months

    questions related to mood and sleep patterns

  5. lipids

    Time frame: change from baseline lipids to 2, 4 (end of treatment) and 5 months (end of follow up)

    lipids will be measured by Ortho Diagnostics analyser from blood

  6. glucose

    Time frame: change from baseline glucose to 2, 4 (end of treatment) and 5 months (end of follow up)

    glucose will be measured by Ortho Diagnostics analyser from blood

  7. telomere shortening

    Time frame: change from baseline length of telomeres to end of the treatment period (4 months)

    telomeres will be measured from peripheral blood mononuclear cells

Sponsors and collaborators

Lead sponsor

Clasado Limited

Industry

Collaborators

  • General Hospital, States of Jersey

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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