Table 1.
Phase 2 Clinical Data
| Reference (Author, date) | Study Design/Duration | Subjects | Purpose | Preparation/Dose | Main Results |
|---|---|---|---|---|---|
| Thom, 2000 [39] | RPCT, 12 weeks | n = 40 (BMI 28-39) | weight loss | 400 mg Phaseolamin® 3X after meals, total 1200 mg/day (other ingred. inulin &Garcinia extract) | ↓body weight, BMI & %body fat in active group (p < 0.05), no effect in placebo group; no between group analysis |
| Erner, 2003 [40] | RPCT, 12 weeks, then open 12 weeks | n = 54 (BMI 24-36) | weight loss | Thera-Slim: 1000 mg Phase2 before 2 meals, total 2000 mg/day | trend toward ↓body weight, 3X decrease in triglycerides; no between group analysis |
| Rothacker, 2003 [36] | RPCT, 12 weeks | n = 88 (BMI 24-32) | weight loss | StarchAway chews: 1000 mg Phase2 before 3 meals, total 3000 mg/day | ↓body weight comparison to placebo (p < 0.05) |
| Udani, 2004 [44] | RPCT, 8 weeks | n = 39 (BMI 30-43) | weight loss | Phase 2 1500 mg 2X, 3000 mg/day | ↓body weight comparison to placebo (ns) ↓trigylcerides (ns) |
| Koike, 2005 [41] | Open, 8 weeks | n = 10 (BMI 23-30) | weight loss | 3 capsules Phaseolamin 1600 diet 2X daily; 750 mg Phase 2 daily | ↓body weight (p = 0.002), calorie intake, BMI, triglycerides & HDL (all p < 0.05) |
| Osorio, 2005 [42] | Open, 30 days | n = 39 (overweight & obese) | Weight loss | PreCarb capsules: 1000 mg Phase3 with meals, total 3000 mg/day | ↓body weight & ↓waist to hip ratio over time (both p < 0.001) |
| Celleno, 2007 [35] | RPCT, 30 days | n = 60 (BMI avg 26) | Weight loss | Phase 2 + chromium; 445 mg extract daily | ↓body weight (p < 0.001), BMI, body fat (both p < 0.01) |
| Vinson, 2009 [45] | PCT, X-over, single dose | Part 1: n = 11, Part 2: n = 7 | Plasma glucose | Phase 2 mixed with margarine or gravy. 750 or 1500 mg. | ↓AUC post prandial blood glucose; higher dose (p < 0.05). |
| Udani, 2009 [46] | RPC, X-over, single dose | n = 13 (BMI 18-25) | Plasma glucose | Phase 2 capsules or mixed w/butter. 1500, 2000, 3000 mg | ↓AUC post prandial blood glucose; 3000 mg w/butter (p < 0.05). |
| Wu, 2010 [37] | RPCT, 60 days | n = 101 (BMI 25-40) | Weight loss | Phase 2; 1,000 mg 3X daily | ↓body weight, waist circumference (both p < 0.01) |
DB = double-blind, PCT = placebo-controlled trial, RPCT = randomized placebo-controlled trial, X-over = crossover