Gut microbiome, dietary patterns, and cognition: bMicrobiome sub-study protocol
This paper describes the development of a readiness-to-change nutritional habits survey integrated with gut microbiome profiling in individuals with cognitive decline.
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What the study showed
The manuscript reports the creation and administration of the 32-item RCNH instrument to characterize participants' willingness to adopt dietary change. The sub-study is nested within a proof-of-concept observational study with 45 participants (HC, MCI, early AD) followed over 6 months. No clinical or microbiome outcomes are reported; this is exclusively a methods paper.
How it was done
Proof-of-concept observational design with data collection at baseline, 3 months, and 6 months. The sub-study develops and applies the RCNH survey alongside gut microbiome profiling, dietary assessment, and cognitive testing.
Risk of bias
Extremely small sample (45 participants, 15 per group), insufficient statistical power for causal inference. As a protocol paper, no outcome data are available for appraisal.
What this study does NOT prove
Does not demonstrate any causal relationship between gut microbiome, diet, and cognitive decline.
In clinical practice
No clinical recommendations can be derived from this publication. The RCNH instrument is experimental and lacks external validation.
Limitations
Extremely small sample (45 participants, 15 per group), insufficient statistical power for causal inference. As a protocol paper, no outcome data are available for appraisal.
Technical appendix
Version history
- 1.0 · 2026-09-10 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.