Table 2 Schedule of assessments and instruments implemented at each study timepoint
Enrolment | Allocation | Study period (weeks) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Timepoint (weeks) | 0 | 0 | 0c | 2 | 4c | 6 | 8 | 10 | 12 | 14 | 16c |
ENROLMENT | |||||||||||
Online pre-screening | ✓ | ||||||||||
Eligibility screen | ✓ | ||||||||||
Informed consent | ✓ | ||||||||||
Randomisation | ✓ | ||||||||||
INTERVENTIONS | |||||||||||
A2 beta-casein only dairy (intervention) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
A1/A2 beta-casein dairy (control) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
ASSESSMENTS (INSTRUMENT) | |||||||||||
Psychological distress (DASS-21) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Severity of depressive symptoms (PHQ-8) | ✓a | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Gastrointestinal symptoms (VAS-IBS) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Stool formation (BSFS) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Functional gastrointestinal disorders (ROME IV module) | ✓ | ✓ | |||||||||
Cognitive assessments (Cogstate) | ✓ | ✓ | |||||||||
Self-reported health/adverse effects | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Perceived wellbeing (WHO-5) | ✓ | ✓ | |||||||||
Quality of life (AQoL-8D) | ✓ | ✓ | |||||||||
Self-reported health care utilisation (Resource use questionnaire) | ✓ | ✓ | |||||||||
Sleep (Athens Insomnia Scale) | ✓ | ✓ | |||||||||
Dietary intake (DQES v3.2) | ✓ | ✓ | |||||||||
Physical activity (IPAQ-SF) | ✓ | ✓ | |||||||||
Personality disorders screener (SAPAS) | ✓ | ||||||||||
Demographics (self-report) | ✓ | ||||||||||
Medications and dietary supplements (self-report) | ✓ | ✓ | |||||||||
Medical conditions and history (self-report) | ✓ | ✓ | |||||||||
Anthropometrics (stadiometer, weighing scales, measuring tape) | ✓ | ✓ | |||||||||
Body composition (DXA) | ✓ | ✓ | |||||||||
Gut microbiota (faecal, 16s RNA faecal analysis, metagenomicsb) | ✓ | ✓ | ✓ | ||||||||
Markers of immune functions (blood, mesoscale discovery platform) | ✓ | ✓ | ✓ | ||||||||
Metabolomics – BCM-7 (blood, HPLC coupled to MS) | ✓ | ✓ | ✓ | ||||||||
Metabolomics – SCFA (faecal, GC-MSb or HPLC analysis of faeces) | ✓ | ✓ | ✓ | ||||||||
Markers of oxidative stress (blood, glutathione assay kits) | ✓ | ✓ | ✓ | ||||||||