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Trial record 83 of 562 for:    maltodextrin

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

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ClinicalTrials.gov Identifier: NCT02716350
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
General Hospital, States of Jersey
Information provided by (Responsible Party):
Clasado Limited

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: B-GOS Dietary Supplement: Maltodextrin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : March 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: B-GOS
powder, 3.5g/day
Dietary Supplement: B-GOS
comparison versus placebo
Other Name: Bimuno

Placebo Comparator: Maltodextrin
powder, 3.5g/day
Dietary Supplement: Maltodextrin
placebo
Other Name: corn starch




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716350


Locations
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United Kingdom
General Hospital Jersey
Saint Helier, Jersey, United Kingdom
Sponsors and Collaborators
Clasado Limited
General Hospital, States of Jersey
Investigators
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Study Chair: Jelena Vulevic, phd Clasado Research Services

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Responsible Party: Clasado Limited
ClinicalTrials.gov Identifier: NCT02716350     History of Changes
Other Study ID Numbers: AGE2016
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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