Version History
Document evolution from initial concept to final design
V1
Initial 3-partner design with DIT focus
V2
Added ECS integration, 4 partners
V3
Budget optimization, equal cohorts
V4
Added DLW subgroup, 4-partner consortium
V5
Removed DLW, increased sample size to n=120
V6
Removed DLW subgroup, streamlined design
V7
Two-study translational design (human + mouse), added Moro
V8
Clarified outcome hierarchy (DIT primary)
V9
Corrected primary objective
V10
Primary objective DIT only
V11
Abstract rewrite, flattened secondary hierarchy
V12
GLP-1 only, expanded biomarkers, mouse strains, wearables
V13
Corrected hypothesis (low DIT = less weight loss), sex-based stratification (60M/60F), added 9-month visit, diabetes exclusion
V14
MAJOR UPDATE: BodPod+BIA at all visits, MRI with AMRA Medical (baseline+M12), muscle function tests, LPMT at M12, 18-month phone follow-up, detailed mouse experiments with individual timelines per strain
Added endocannabinoid system (ECS) integration based on Prof. Dalle's expertise
Expanded consortium to 4 partners with Maastricht University (Prof. Plasqui)
Removed invasive procedures (BAT imaging, biopsies) based on Guillermo's feedback
Finalized streamlined observational design with n=120
| Feature | v1 | v4 | v6 (Final) |
|---|---|---|---|
| Sample Size | n=96 | n=96 | n=120 |
| Partners | 3 | 4 | 4 |
| BAT Imaging | ✓ | ✓ | Removed |
| Muscle Biopsies | ✓ | ✓ | Removed |
| DLW Validation | - | ✓ | Removed |
| Metabolic Flexibility | - | - | Added |
| ECS Profiling | - | ✓ | ✓ |
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