Evaluations and procedures | Â | Baseline | Week 4 | Week 24 |
---|---|---|---|---|
Screening | (day −14 to day 0) | (day 28 to day 35) | (day 160 to day 174) | |
Informed consent and HIPAA authorization | OR, SV1 | Â | Â | Â |
Randomization | Â | Day 0 | Â | Â |
Anthropometrics and body composition | Â | Â | Â | Â |
 Height | RI1, SV1 |  |  |  |
 Waist and hip circumference | SV1 |  | Day 28 | Days 160, 174 |
 Weight | RI1, SV1 | Days −14, −7, 0 | Days 28, 35 | Days 160, 167, 174 |
 Blood pressure and heart rate | RI1, SV1 |  | Day 28 | Days 160, 174 |
 ECG | SV1 |  |  | Day 160 |
 DXA |  | Day −14, 0 |  | Days 160,174 |
Energy metabolism | Â | Â | Â | Â |
 TEE based on DLW measurement |  | Day −14 |  | Day 160 |
 Daily weight |  | Day −14 to day 0 |  | Day 160 to day 174 |
 Urine collection |  | Days −14, −7, 0 |  | Days 160, 167, 174 |
 RMR |  | Day −14 |  | Day 160 |
Physical activity | Â | Â | Â | Â |
 Accelerometry | RI2 | Day −14 | Day 28 | Day 160 |
 VO2max | SV2 |  |  | Day 163 |
Psychological questionnairesb |  | Day −14 | Day 28 | Day 160 |
Clinical chemistry panel (CBC, chem 15) | SV1 | Â | Â | Day 160 |
Food intake tests with VAS |  | Day −4 | Day 28 | Day 170 |
 Blood collection for satiety hormone archivec |  | Day −4 |  | Day 170 |