Table 1.
Standard protocol items: recommendations for interventional studies (SPIRIT).
| Enrolment | Visit 1 (baseline) | Visit 2 (week 6) | Visit 3 (week 12) | |
|---|---|---|---|---|
| Eligibility screening | X | |||
| Informed consent | X | |||
| Information sheet | X | |||
| Capsules provision | X | |||
| Hypocaloric diet explanation | X | |||
| Dietary, physical activity, and lifestyle assessment | ||||
| Lifestyle and backgrounds | X | |||
| Physical Activity | X | X | X | |
| 24-h Dietary Recall | X | X | X | |
| 3-day Dietary Record | X | X | X | |
| Physical assessment | ||||
| Anthropometrics | X | X | X | |
| Bioimpedance | X | X | X | |
| Blood pressure | X | X | X | |
| Biochemical assessment | ||||
| Blood lipids and sugar | X | X | X | |
| Renal, hepatic, and thyroid function markers | X | X | X | |
| Inflammatory biomarkers | X | X | X | |
| Metabolomics | X | X | X | |
| Microbiota composition | X | X | ||