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

NCT02716350 | Completed DMC

• 1 other identifier: AGE2016
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• α1-antitrypsin

  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

  measured monthly for 5 months

• questionnaire as a measure of mood

  measured monthly for 5 months

• lipids

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

Study Arms (2)

B-GOS

EXPERIMENTAL

powder, 3.5g/day

Dietary Supplement: B-GOS

Maltodextrin

PLACEBO COMPARATOR

powder, 3.5g/day

Dietary Supplement: Maltodextrin

Interventions

B-GOS DIETARY_SUPPLEMENT

comparison versus placebo

Also known as: Bimuno

B-GOS

Maltodextrin DIETARY_SUPPLEMENT

placebo

Also known as: corn starch

Maltodextrin

Eligibility Criteria

• Age: 52 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clasado Limited: lead
• General Hospital, States of Jersey: collaborator

Study Sites (1)

General Hospital Jersey

Saint Helier, Jersey, United Kingdom

Location

MeSH Terms

Interventions

maltodextrin; Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Jelena Vulevic, phd

  Clasado Research Services

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)