Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01358890 | Low-Carbohydrate Diet Intervention on Body Weight | PHASE2 | COMPLETED | 50 | — | — | May 1, 2011 | Aug 1, 2011 | Feb 28, 2012 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| B | EXPERIMENTAL | Subjects will be supplied with low carbohydrate diet for 12 weeks. |
| A | EXPERIMENTAL | Subjects will be supplied with calories restricted diet for 12 weeks |
| Name | Type | Description |
|---|---|---|
| low carbohydrate diet | OTHER | Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day |
| Calories restricted diet | OTHER | Total energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively |
Inclusion Criteria: * overweight/obese (BMI ≥24 kg/m2) Exclusion Criteria: * Pregnancy or lactation; * Serum creatinine and blood urea nitrogen level beyond the clinical reference value; * alanine aminotransferase and aspartate aminotransferase beyond the reference levels; * Gastrointestinal prob...