Older people (aged 70+ years) living in the community Not Applicable
Conditions
Interventions
Participants will be given IDs from 001 to 104. These IDs have been randomly allocated to treatment groups using a randomisation programme, with randomisation stratified for sex based upon a 50:50 dis
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Community dwelling males and females aged 70+ years 2. Body mass index 18.5-35 kg/m² 3. Willing to adhere to the study protocol 4. 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 prescribed vitamin D or calcium+vitamin D 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. Blood donation in the previous 3 months 8. Participation in any other clinical trial in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at study entry and exit (week 12): 1. Serum 25-hydroxyvitamin D3 concentration (nmol/l) measured by immunoassay 2. Colonisation with the probiotic organism detected in faeces (number of organisms per g faeces) measured by 16S RNA 3. Serum CRP concentration measured by ELISA (mg/dl) | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured 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 markers (mg/l) measured by immunoassay 3. Faecal microbiome taxonomy (numbers of different organisms per g faeces) measured by 16S RNA 4. Weight (kg), body mass index (kg/m²), body fat mass (kg and % body weight), body lean mass (kg and % body weight), mid arm upper circumference (cm), waist circumference (cm), hip circumference (cm), waist:hip ratio, measured by weighing scales, tape measure and bioelectric impedance 5. Hand grip strength (kg) measured using a dynamometer 6. Dietary intake (amounts of foods and nutrients) measured using the EPIC food frequency questionnaire and intake24 recall 7. Quality of life (questionnaire plus visual analog scale) measured using the EQ5D5L questionnaire 8. Physical activity measured using the Physical Activity Scale for the Elderly (PASE) questionnaire 9. Respiratory symptoms measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS) 10. Blood glucose (mml/l), insulin (U/l) and HOMA-IR measured by enzyme-linked colorimetric assays 11. Blood lipids (total, LDL and HDL cholesterol, triglycerides; all mmol/l) measured by enzyme-linked colorimetric assays 12. Blood adipokines (leptin, adiponectin, leptin/adiponectin ratio, visfatin and resistin; mg/l) measured by ELISA 13. Blood markers of intestinal barrier integrity (mg/l) measured by ELISA 14. Blood PTH (pg/ml) and calcium (mg/dl), as markers of vitamin D homeostasis 15. Faecal metabolome measured by nuclear magnetic resonance (NMR) 16. Urinary metabolome measured by NMR | — |
Countries
England, United Kingdom
Outcome results
None listed