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Table 1 Phase 2 Clinical Data

From: A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): A review of clinical studies on weight loss and glycemic control

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)
  1. DB = double-blind, PCT = placebo-controlled trial, RPCT = randomized placebo-controlled trial, X-over = crossover