Immunosenescence
Conditions
Brief summary
The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people
Interventions
DIETARY_SUPPLEMENTBi2muno® GOS
5.5g/day for 10 weeks
DIETARY_SUPPLEMENTMaltodextrin
5.5g daily for 10 weeks
Sponsors
University of Reading
Clasado
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 65 and 80 years of age. * In good general health * The volunteer has given written informed consent to participate and is willing to participate in the entire study.
Exclusion criteria
* History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years. * Family history of colorectal cancer in under 50's * Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks. * 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 (please note sensory evaluations are still permitted). * 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). * Smoker * Lactose intolerant * Allergic to gluten * Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication. * Intention to use regularly other medication which affects gastrointestinal motility and/or perception. * History of alcohol or drug misuse. * Suffer from any major conditions involving the following: Head, Ears, Eyes, Nose and Throat Dermatological/Connective tissue Coeliac disease Neurological Lymphatic Urogenital/Rectal Gastroenterological Abdominal Respiratory Cardiovascular Incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers | 12 months |
| Effect of B-GOS on the faecal microbiota composition of elderly persons | 12 months |
| Effect of aging on body metabolites using NMR | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Effect of B-GOS on gut permeability | 12 months |
| Weekly assessment of stools and gastrointestinal symptoms | 8 months |
Countries
United Kingdom
Outcome results
None listed