And timeline of advances and milestones for amylase inhibitors and Phaseolus vulgaris as Phase 2
The active ingredient in Dietitian’s Select Weight Loss Formula
Findings and benefits indicated in red.
2018 — Dietitian’s Select Nutrition Products LLC) launches Dietitian’s Select Weight Loss Formula™, a state-of-the-science weight loss aid containing active ingredient – Phaseolus vulgaris as Phase 2. Phase 2 is a trademark of Pharmachem Labs and is used under licensing agreement with Dietitian’s Select Nutrition Products LLC via Vitalabs, Inc..
2013 — A study was conducted in two phases to demonstrate the safety and efficacy of Phase 2 (IQP-PV-101) in weight management in obese and overweight Caucasian adults. The weight loss phase was a 12-week randomized, double-blind, placebo-controlled study where all subjects followed a strict diet plan; the second phase was the weight maintenance study over 24 weeks, where the subjects’ energy intake was ad libitum. Results showed that those subjects taking Phase 2 lost significantly more weight than those on placebo after 12 weeks, in fact, researchers saw a marked difference starting in week 4 onward . Notably more subjects in the IQP-PV-101 group lost at least 5 percent of their baseline body weight. In the weight management phase, 73.5% of participants successfully maintained their body weight after 24 weeks. (“Weight Reduction and Maintenance with IQP-PV-101: A 12-Week Randomized Controlled Study with a 24-Week Open Label Period,” Barbara Grube, Wen-Fen Chong, Pee-Win Chong and Linda Riede, Obesity, published online 2013).
2011 — A review of over a dozen separate studies confirmed that Phase 2 Carb Controller demonstrated the ability to cause weight loss with doses of 500 to 3000 mg per day, in either a single dose, or in divided doses. The studies also showed that the ingredient has the ability to reduce the postprandial spike in blood glucose levels. (“A proprietary alpha-amylase inhibitor from white bean [Phaseolus vulgaris]: A review of clinical studies on weight loss and glycemic control,” Marilyn L. Barrett, Pharmacognosy Consulting, Jay K. Udani, MD, Medicus Research LLC, Nutrition Journal, March 2011).
2010 — In this 2010 Chinese study, 101 volunteers with a BMI between 25 and 40 were given a single capsule containing 1,000 mg Phase 2 or placebo three times per day (3,000 mg total), just before meals, for 60 days. Significant weight loss was observed in the active groups compared to the placebo group after 30 and 60 days. After 60 days, the average weight loss in the active group was 4.18 pounds (1.9kg) ± 0.15 kg compared to 0.88 pounds (0.4kg) ± 0.13 kg in the placebo group (p<0.001). There was also a significant reduction in waist measurement in the active group compared to the placebo group (1.9 ± 0.32 cm compared to 0.4 ± 0.26 (p<0.001).Wu X, Xu X, Shen J, Perricone N, Preuss H: Enhanced weight loss from a dietary supplement containing standardized Phaseolus vulgaris extract in overweight men and women. Journal of Applied Research 2010, 10: 73-79.
2009 — In a placebo-controlled, cross-over study, 11 fasting subjects (men and women aged 21 to 57) received four slices of white bread and 42 g (3 Tbsp) of margarine–some of which featured 1500 mg of Phase 2. The food contained a total of 610 calories; 60.5 came from carbohydrate. Compared to the control group, the glucose levels following consumption of Phase 2 returned to baseline 20 minutes earlier. The area under the plasma glucose vs. time curve (see chart on top of page 8) was 66 percent lower with Phase 2 compared to the control (p<0.05). The authors concluded that 1/3 of the carbohydrates in the bread were absorbed. Vinson J, Al Kharrat H, Shuta D: Investigation of an amylase inhibitor on human glucose absorption after starch consumption. The Open Nutraceuticals Journal 2009, 2: 88-91.
— A six-arm, cross-over study determined whether the addition of Phase 2 would lower the GI of white bread, a high GI food. Subjects received standardized GI testing after eating white bread 8 9 with butter. Phase 2 was given t capsule or powder forms of 1,500, 2,000, and 3,000 mg; the powdered form was mixed with the butter. Ultimately, the 3, 000 mg dose caused a 34.11% percent reduction in postprandial glucose levels. Udani JK, Singh BB, Barrett ML, Preuss HG: Lowering the glycemic index of white bread using a white bean extract. Nutr J 2009, 8: 52.
2008 — Although obesity and diabetes are on the increase worldwide, based on research developments discussed, the common bean (P. vulgaris) alpha-amylase inhibitor has potential to serve as a widely used remedy against these conditions. (“The Nutraceutical role of Phaseolus vulgaris alpha-amylase inhibitor,” Wokadala Cuthbert Obiro, Tao Zhang, Bo Jiang; State Key Laboratory of Food Science & Technology, Southern Yangtze University, Jiangsu, China; British Journal of Nutrition, 2008, 100,
— A two-year, randomized study showed that a low-carb diet helped people lose more weight than a Mediterranean-style diet and the traditional low-fat diet. (“Weight Loss with a Low-Carbohydrate, Mediterranean, or Low-Fat Diet,” Michael, Stumvoll, M.D., and Meir J. Stampfer, M.D., Dr. P.H., et al, The Dietary Intervention Randomized Controlled Trial (DIRECT) Group, The New England Journal of Medicine, July, 2008, Vol. 359, No. 3, pages 229-41.
— (“Alterations in Hepatic Glucose and Energy Metabolism as a Result of Calorie and Carbohydrate Restriction,” Jeffrey D. Browning, Brian Weis, Jeannie Davis, Santhosh Satapati, Matthew Merritt, Craig R. Malloy and Shawn C. Burgess,” Hepatology, November, 2008. —
— A randomized, double-blind, placebo-controlled study of 101 subjects showed that those receiving Phaseolus vulgaris extract (Phase 2) had clinical and significantly greater average reduction of body weight and waist circumference, but essentially no difference in average hip circumference. (“Enhanced weight loss from a Dietary Supplement Containing Standardized Phaseolus Vulgaris Extract in Overweight Men and Women,” Jianguo Shen, M.D., Xiaofeng Xu, M.S., Allesandro D’Amore, M.D., Harry Preuss, M.D., MACN, CNS.
2007— Healthy overweight subjects who took 1,000 mg of Phase 2 twice a day while exercising and adhering to various guidelines for four weeks lost more weight and more inches from their waist compared to those following the same course of action who took placebo. Udani J, Singh BB: Blocking carbohydrate absorption and weight loss: clinical trial using a proprietary fractionated white bean extract. Altern Ther Health Med 2007, 13: 32-37.
— A scientific study was conducted to determine the stability of Phase 2/StarchLite in processed foods and develop a method for monitoring its alpha-amylase inhibiting activity. The study showed that the alpha-amylase inhibiting action of Phase 2 was not affected during preparation of instant mashed potatoes. It also showed that exposure of alpha-amylase to Phase 2 for 30 minutes resulted in significant inhibition(of starch). (Yesu Das, Ph.D., ISSI Laboratories, Inc., Piscataway, NJ).
— A study was conducted to assess the efficacy of Phase 2/StarchLite in inhibiting the human salivary alpha amylase in chewing gum. The study showed that alpha amylase was significantly inhibited by Phase 2 and the inhibiting action of Phase 2 was not affect by the processing/ manufacturing of the chewing gum. (Yesu Das, Ph.D., ISSI Laboratories, Inc., Piscataway, NJ).
— Studies were conducted on Super Bows Diet Type B, a supplement in the Japanese marketplace that Confidential; for authorized distribution, only contains Phase 2, to evaluate its effect on body weight, body fat and blood glucose levels. In an 8-week open test on 47 human subjects who took Super Bows Diet Type B, there was a significant decrease in the body weight and body fat percentage of test subjects after 8 weeks. In a double-blind cross-over test of 13 human subjects, those who took Super Bows Diet Type B had blood glucose and insulin levels 30 minutes after intake that were significantly lower than those on placebo. (“Effects of Combination of Functional Food Materials on Body Weight, Body Fat Percentage, Serum Triglycerides and Blood Glucose” Yamamoto Tetsuro, Yamaguchi Hideyo, TTC Co. Ltd.)
— Krishnan S, Rosenberg L, Singer M, Hu FB, Djousse L, Cupples LA et al.: Glycemic index, glycemic load, and cereal fiber intake and risk of type 2 diabetes in US black women. Arch Intern Med 2007, 167: 2304-2309.
— Villegas R, Liu S, Gao YT, Yang G, Li H, Zheng W et al.: Prospective study of dietary carbohydrates, glycemic index, glycemic load, and incidence of type 2 diabetes mellitus in middle-aged Chinese women. Arch Intern Med 2007, 167: 2310-2316.
2006 — An open-label 6-arm crossover study with 13 randomized subjects using standardized GI testing showed that the GI of Wonder Brand White Bread was significantly reduced by the addition of 3000mg of the Phase 2/StarchLite white bean extract in powder form with other dosages and formulations trending toward significance. (“A Novel Method of Lowering the Glycemic Index of White Bread Using a Proprietary White Bean Extract,” Jay Udani, MD Medical Director, Medicus Research)
2005 — An 8-week trial of 10 overweight subjects showed that those who took PhaseolaminTM 1600 diet reduced body weight, body fat ratio, body fat, abdomen fat ratio, BMI, waist-hip size and triglycerides in the blood serum at a statistically significant level. In addition, the basal metabolism quantity per weight (kg.) was increased at a statistically significant level. (“The Anti-Obesity Effect and the Safety of Taking Phaseolamin1600 Diet,” Takashi Koike, Yoshimitsu Koizumi, Liang Tang, Kyouko Takahara, Yasuhiro
Saitou; J. New Rem & Clin, Vol. 54, No. 7; 2005)
— A 30-day study of 50 overweight and obese subjects revealed that 98% of those completing the study (74%) obtained positive results by reducing their body weight with no special eating regimen and no additional exercise; no adverse reactions or gastrointestinal discomfort were reported. (“Random MultiCenter Evaluation to Test the Efficacy of Phaseolus Vulgaris [PreCarb/Phase 2] in Obese and Overweight Subjects; Lucilla Velasso Osorio, dietitian, Jorge Alberto Zavola Gamboa, Q.I.”
2004 — A double-blind, human pilot study found that those who ate the most carbohydrates and took a supplement containing Phase 2 Starch Neutralizer→, lost significantly more weight and inches from their waist than the placebo group. When stratified by total carbohydrate intake, the Phase 2 group lost an average of 8.7 lbs and 3.3 inches off their waists, while the placebo group lost an average of 1.7 lbs and 1.3 inches. The results were statistically significant. Triglyceride levels in the Phase 2 group were reduced by an average of 26.3 mg/dl, more than three times the average reduction of 8.2 mg/dl seen in the placebo group (p=0.07). (“Blocking Carbohydrate Absorption and Weight Loss: A Clinical Trial Using a Proprietary Fractionated White Bean Extract” Jay Udani, MD, Medical Director, Integrative Medicine Program, Northridge Hospital Medical Center, Northridge, CA; Betsy Singh, Ph.D., Dean of Research, Southern California University of Health Sciences. Alternative Therapies in Health and Medicine, Jul/Aug 2007, Vol. 13, No.4.)
— A randomized, double-blind, placebo-controlled, cross-over study of 54 overweight and obese subjects showed minor weight loss and favorable alterations of BMI in some of the stratified groups; several statistically significant favorable changes in blood pressure in the single arm prospective study; and statistically significant improvement in total cholesterol levels in all stratified groups. (“The Effect of TheraSlim [with Phase 2] on Weight, Body Composition, and Select Laboratory Parameters in Adults with Overweight and Mild-Moderate Obesity,” Stuart I. Erner, M.D., bariatric physician and researcher, integrative medicine practice).
— Schulze MB, Liu S, Rimm EB, Manson JE, Willett WC, Hu FB: Glycemic index, glycemic load, and dietary fiber intake and incidence of type 2 diabetes in younger and middle-aged women. Am J Clin Nutr 2004, 80: 348-356.
2003 — A double-blind, placebo-controlled study of 27 subjects showed that those taking Phase 2 lost nearly a half pound per week (3.8 lbs. over eight weeks), on average, or 129% more than those on placebo. Those on placebo lost 1.65 lbs. Patients on the starch neutralizer also lost 1.47 inches around their waists, on average, or 36% more than those on placebo. Those on placebo lost 1.07 inches. (“Blocking Carbohydrate Absorption and Weight Loss: A Clinical Trial Using Phase 2 Brand Proprietary Fractionated Bean Extract,” Jay Udani, MD, Mary Hardy, MD, and Damian C. Madsen, B.A., Alternative Medicine Review, Volume 9, Number 2, March 2004).
2002 — A double-blind, placebo-controlled, cross-over pilot study of 11 adult human subjects showed that starch absorption averaged 66% less in the group taking Phase 2. (Joe A. Vinson, Ph.D., and Donna M. Shuta, B.S., Department of Chemistry, University of Scranton, April 24, 2002).
— After critical independent evaluation of the available safety and clinical information, the undersigned experts conferred and, anticipating imminent publication of the 28-day rodent study manuscript, concluded that Phase 2 may be Generally Recognized as Safe (GRAS) by scientific procedures providing an upper limit of aggregate intake of 6 g of Phase 2 per day from supplement and qualified food use applications,” (Evaluation of the Generally Recognized as Safe (GRAS) Status of Phase 2 White Bean (Phaseolus Vulgaris) Extract, Robert Nicolosi, Ph.D., Donald Hughes, Ph.D., and David Bechtel, Ph.D.)
2001 — A double-blind, placebo-controlled study of 60 human subjects who took Phase 2 lost an average of 6.45 lbs. in 30 days, compared to those on placebo, who lost less than 1 lb., on average. Those participants on Phase 2 also lost, on average, over 10% of body fat mass, and more than 3% in waist circumference. There was no loss of lean body mass. (Dr. Licia Tiberi, EVIC Italia. “A Dietary Supplement Containing Standardized Phaseolus Vulgaris Extract Influences Body Composition of Overweight Men and Women.” Celleno L, Tolaini MV, D’Amore A, Perricone NV, Preuss HG. Int. J. Med. Sci., 2007; 4:45-52.
1999 — A double-blind, placebo-controlled study of 40 overweight human subjects showed that those who took a supplement containing Phase 2 several times a day for 12 weeks experienced statistically significant weight loss and BMI reduction. The Phase 2 supplement had a significantly greater effect on body weight than did the placebo (weight loss of 3.5 kg vs. 1.2 kg). In addition, body mass analyses show that the weight loss in the active group consisted mainly of fat loss as >85% of the weight loss was accounted for by fat. (Dr. E. Thom, Parexel Medstat AS, Lillestrom, Norway. “A Randomized, Double-Blind, Placebo Controlled Trial of a New Weight-Reducing Agent of Natural Origin” Journal of Int’l Medical Research 2000; 28: 229-233)
1984-88 — Mayo Clinic begins a series of studies. Major findings include amylase inhibitors cause dose-dependent intraluminal amylase inactivation. http://www.mayoclinicproceedings.org/article/S0025-6196(12)61978-8/fulltext?mobileUi=0, ,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071778/, https://www.mayoclinicproceedings.org/article/S0025-6196(12)61978-8/abstract, ,
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