People aged 60 + years living in the community Other
Conditions
Interventions
Participants will be sought through poster advertisements
articles in the media (newsletters, newspapers, radio, and university project-specific social media pages)
posters and email within the University of Southampton and University Hospital Southampton NHS Foundation Trust
and by contacting those on a GDPR compliant database held by the University Hospital Southampton. The study involves making two visits to the Clinical Research Facility at University Hospital Southamp
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Community-dwelling males and females aged 60 years and older 2. Body mass index of 18.5-30 kg/m2 3. Have regular bowel movements 4. Willing to adhere to the study protocol 5. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Living in a care or nursing home 2. Diagnosed with diabetes or other metabolic and endocrine disorders 3. Presence of active gastrointestinal disease (coeliac disease, Crohn’s disease, diagnosed IBD etc.), autoimmune disease, or inflammatory disease (lupus, rheumatoid arthritis, multiple sclerosis) 4. Use of prescribed medicine to control inflammation (e.g. non-steroidal anti-inflammatory drugs; NSAIDs) or regular use of over-the-counter NSAIDs 5. Use of dietary supplements (will allow a 4-week washout period) 6. Use of probiotic drinks or yoghurts (will allow a 4-week washout period) 7. Have extreme habitual fibre intake (lower than 10 g per day or higher than 30 g per day) based on a validated fibre screening tool 8. Blood donation in the previous 3 months. 9. Participation in any other clinical trial in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood neutrophil phagocytosis of E. coli measured as median fluorescence intensity using flow cytometry, reflecting the number of bacteria taken up per neutrophil, at study entry and exit (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes are assessed at study entry and exit (12 weeks) 1. Blood immune cell phenotypes (number of each cell type per microlitre of blood) measured by flow cytometry 2. Plasma inflammatory cytokines and chemokines (mg/l) measured by multiplex immunoassay 3. Plasma C-reactive protein (mg/l) measured by immunoassay 4. Blood monocyte phagocytosis of E. coli measured as median fluorescence intensity by flow cytometry 5. Blood natural killer cell activity measured as % killing to K562 target cells by flow cytometry 6. Blood T cell response to stimulation with Con A measured as CD69 expression (flow cytometry) and immunoregulatory cytokine production (multiplex immunoassay) 7. Blood monocyte response to stimulation with LPS measured as immunoregulatory cytokine production (multiplex immunoassay) 8. Faecal microbiota measured as the numbers of different organisms/g faeces by 16S RNA sequencing 9. Faecal short-chain fatty acid concentrations (mmol/l) measured by gas chromatography 10 Faecal calprotectin and intestinal fatty acid binding protein (mg/l) measured by immunoassay 11. Plasma short-chain fatty acids (mmol/l) measured by gas chromatography 12. Urinary metabolome measured by nuclear magnetic resonance 13. Gastrointestinal health measured by questionnaire and Bristol Stool Chart score 14. Energy (cal/day) and macronutrient (g/day) intake measured by a food frequency questionnaire (FFQ) | — |
Countries
England, United Kingdom
Contacts
Public ContactPhilip Calder
Outcome results
None listed