Date

2026-09-28

Protocol

Protocol changed

Item Changed

Secondary outcome(s) - Time of assessment(s)

Previous Version

Baseline (Week 0) Middle of the intervention (Week 13) Post-Intervention (Week 26)

Next Version

Outcome -Anthropometric parameters Time of assessment- Baseline (Week 0), Middle of the intervention (Week 13), Post-Intervention (Week 26). Outcome - Biochemical parameters Time of assessment- Baseline (Week 0), Post-Intervention (Week 26). Outcome - rs17782313 polymorphism in the MC4R gene Time of assessment- Baseline (Week 0) . “Time of assessments” of anthropometric & biochemical parameters – This change is made to improve clarity by clearly stating the assessment time points. Anthropometric parameters will be assessed at three time points, while biochemical parameters will be assessed at two time points. Gene polymorphism is a newly added component for which REC approval was granted (Time of assessment -Baseline week 0).