Inflammation and well-being Other
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects over 18 years of age and under 60 years of age 2. Subjects who are able to commit to multiple visits to WARU 3. Subjects who can provide venous blood samples, urine samples, and saliva samples 4. Subjects able to provide written informed consent prior to performing any study procedures
Exclusion criteria
Exclusion criteria: 1. Subjects with a diagnosis of Alzheimer’s disease or other forms of dementia 2. Subjects taking medication for the treatment of dementia (such as acetylcholinesterase inhibitors (Aricept, Excelon), memantine (Namenda) or other medications with similar mechanisms of action) or medical foods (such as Cerefolin, Souvenaid, Axona) for the treatment of dementia. 3. Subjects who are pregnant or lactating 4. Subjects with medical condition or disease that is life-threatening 5. Subjects diagnosed with diabetes. 6. Subjects already consuming pro-biotics who will not comply with the 4-week washout 7. Subjects with any cardiovascular diseases 8. Subjects with severe physical illnesses (e.g., fibromyalgia) 9. Subjects experiencing hypertension (high blood pressure) 10. Subjects with endocrine disorders 11. Subjects suffering from substance abuse 12. Subjects who heavily smoke (>10 cigarettes/day) 13. Any medication known to affect the HPA axis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life is measured by the EuroQol -5D-5L at baseline and after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychological well-being measured using the Carol Ryffs (1989) Psychological Well-Being (PWB) Scale (18-item) at baseline and after 8 weeks 2. Emotional states of depression, anxiety and stress measured using the Depression Anxiety Stress Scale (DASS; 21-item) at baseline and after 8 weeks 3. Mood or emotion measured using the Positive and Negative Affect Scale (PANAS)-GEN at baseline and after 8 weeks 4. Pain measured using the Visual Analogue Scale (VAS) at baseline and after 8 weeks 5. Near global metabolomics of first morning void urine measured by flow injection using electro-spray mass spectrometry instrumentation at baseline and after 8 weeks 6. Stress measured by cortisol concentrations in saliva before and after the Maastricht Acute Stress Test (MAST) at baseline and after 8 weeks 7. Near global metabolomics of fasting plasma measured by flow injection using electro-spray mass spectrometry instrumentation at baseline and after 8 weeks 8. Inflammation measured by cytokine analysis (TFN-alpha) of fasting serum using ELISA at baseline and after 8 weeks | — |
Countries
United Kingdom, Wales