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

Barrett and Udani Nutrition Journal 2011 10:24   doi:10.1186/1475-2891-10-24

Open Data