2.4. Study Assessment and Outcomes
Eligible participants completed a clinic assessment visit and faecal sample collection (for gut microbiome analysis) at the start (weeks 0 and 16) and at the end (weeks 8 and 24) of each diet intervention phase. To determine the effect of a MedDairy diet on the gut microbiota, changes to the gut microbiota between baseline of the intervention phase and at the end of the 8-week diet intervention, for the MedDairy or LFD diet, were assessed. Between-group differences at the end of the 8-week diet intervention were also assessed to determine MedDairy diet-specific effects on bacterial relative abundance. The exploratory outcomes were associations between changes in MedDairy diet-specific bacterial relative abundance and changes in clinical, anthropometric, and cognitive function measurements. Clinical measures include blood pressure (systolic and diastolic blood pressure at a clinic or self-measured), blood levels of insulin, glucose, HOMA-IR, C-reactive protein, total triglyceride, total cholesterol, HDL, LDL, and cholesterol:HDL ratio [