Starch Neutralizer Promotes Weight Loss, Lowers Triglyceride Levels
For Release: AT WILL
Contact: Tom McCartney
(412) 361-5178
tommc@pgh.net

KEARNY, NJ, DEC. 10, 2002—Patients who took a concentrated starch neutralizer extracted from the white kidney bean, lost nearly a half pound per week (3.8 lbs. over eight weeks), on average, or better than 200% more than those on placebo. Patients on the starch neutralizer also lost 1.5 inches around their waists, on average, or 43% more than those on placebo.

“The results are encouraging, and look very promising,” said chief researcher, Jay Udani, M.D., Medical Director, Integrative Medicine Program, Northridge Hospital Medical Center, Los Angeles, CA.

“One of the most surprising results of the study was the impact that the starch neutralizer had on triglycerides, a form of bad cholesterol,” said Udani. “There was a dramatic, 26-point drop in triglyceride levels, on average, for patients taking the starch neutralizer, while those on placebo averaged only an 8 point drop in triglyceride levels. The difference between the two groups was more than 300%.

“The ability of this product to reduce triglycerides may be an important adjunct in maintaining a good cardiac profile.”

Another surprising result, according to Udani, was the effect of the starch neutralizer on energy levels.

“Those patients on the starch neutralizer reported a 13% increase in energy, while those on placebo reported no improvement in this area. This is important because the starch neutralizer is not a stimulant.”

No significant adverse effects from the starch neutralizer were reported by any of the patients participating in the study.

Pharmachem laboratories, Kearny, NJ, is the supplier of Phase 2® starch neutralizer. The company develops, supplies and manufactures a variety of high-quality, efficacious food supplements standardized for specific potency, solubility, direct compression and disintegration characteristics. The Company operates four processing and manufacturing facilities in Northern New Jersey, including the H. Reisman Corporation. Pharmachem also owns American Ingredients, Anaheim, CA.

Chronic Toxicity Study Confirms Safety of Phase 2® Ingredient
For Release: AT WILL
Contact: Tom McCartney
(412) 361-5178
tommc@pgh.net

KEARNY, NJ, NOV. 5, 2002--Pharmachem Laboratories, Inc., today announced that a Chronic Toxicity Study (L.D.50) demonstrated that Phase 2 Starch Neutralizer™, the first standardized white bean extract used in a variety of weight loss supplements, is safe and non-toxic.
“Phase 2® showed no signs of chronic toxicity at doses up to 1.0 gm/kg body weight for up to 90 days,” said Ramadasan Kuttan, Ph.D., director, Amala Cancer Research Center, Thrissur, India, who conducted the study along with R. C. Srimal, M.D. “The data indicates that administration of Phase 2® for 90 days did not produce any adverse reaction as seen from the organ weight, necropsy, haematological values and biochemical values.”
Additional findings of the study were as follows:
• There was no significant weight changes in any of the animals.
• Food consumption in the Phase 2® groups (1 gm and 5 gm) was found to be decreased significantly, especially after two months of treatment, compared to controls.
• Liver function tests indicated that chronic administration of Phase 2® at the doses given did not produce any change in the liver function tests such as GOT, GPT, ALP, Bilirubin, total protein and Albumin/Globulin ratio.
• Chronic administration of the Phase 2® did not produce any change in the renal function as indicated from serum urea, creatinine and electrolyte levels.
• Chronic administration of Phase 2® did not produce any change in the haematological parameters such as total WBC, differential count and platelets.
• There was no change in necroscopy of the animals and organ weight of the animals such as liver, kidney, spleen were unchanged.
• There was no significant change in the lipid profile of animals treated with Phase 2® • Histopathology of liver and kidney of the Phase 2® -treated groups was normal and similar to controls.
An LD 50 study for acute toxicity, conducted earlier this year, also confirmed that Phase 2® is “safe and non-toxic.”

Acute toxicity study of Phase 2® Starch Neutralizer™ (Phase 2® )
Pharmachem Laboratories, Inc,
Kearny, NJ.

Procedures
One hundred and sixty Wistar rats of both sex *80 males & 80 females) were used for the experiment. They were purchased from National Centre for Laboratory Animal Sciences, Hyderabad, India. Animals were selected at random; divided into sixteen groups, each group consists of 5 male and 5 female rats. Three dose ranges of the products used were (5 g/kg body wt; 1 g/kg body wt; 0.2 g/kg body wt). The agents were prepared in distilled water as the vehicle. The suspensions were made using a mortar and pestle. The animals were divided as follows:
Treatment Dose No.& Sex
     
Control (without any drug)   5 males & 5 females
Phase 2® 5 g/kg body wt. 5 males & 5 females
Phase 2® 1 g/kg body wt. 5 males & 5 females
Phase 2® 0.2 g/kg body wt. 5 males & 5 /kg body wt.
The rats were kept in plastic cages and fed with pelleted rat feed (Sai Durga Agencies, Bombay) and water ad libitum. The products were administered orally in the prescribed dose using an oral needle, on the first day of the experiment. Rats were monitored for a period of 14 days for mortality and any adverse reaction of the drugs. Food consumption and body weight were measured every third day. The food consumption was determined by the following method. The food particles were removed from the cages and a known amount of food was added to the cage; on the next day, the food left in the cages were collected and weighed.
After 14 days, the animals were sacrificed by vertibral dislocation, blood was collected by direct heart puncture method. Necropsy and histological evaluations were also made and photographs were taken.
From half portion of blood collected from each animal, serum was separated.
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November 20 - In vivo effectiveness of a starch absorption blocker in a double-blind placebo-controlled study with normal college-age subjects.
Joe A. Vinson, PhD and Donna M. Shuta, BS
Department of Chemistry
University of Scranton
Scranton, PA 18510

Inhibition of carbohydrate metabolism or absorption is one mechanism to reduce hyperglycemia in normal and especially in diabetic subjects. Another possible benefit is the decrease in calorie intake after eating carbohydrates for obesity and weight loss. In the 1980's there were several reports of in vitro and in vivo effectiveness of a natural starch blocker that worked by inactivating the enzyme amylase. We investigated this hypothesis with an initial pilot study. After this initial study with subjects who were physically active during the study, we did a second study to confirm the results. In this second study, again there was a double-blind placebo-controlled crossover trial with ten subjects (five males and five females aged 21 to 27) who participated with informed consent. After an overnight fast the subjects appeared in the morning and were given in a random fashion either 1) placebo consisting of 4 slices of white bread (60 g of carbohydrate), 42 g of soybean oil margarine, and 4 g of Sweet N'Low; 2) experimental comprising the control plus 1.5 g of Phase 2® (Pharmachem Laboratories). The subjects rested between blood drawings. Plasma glucose was measured from blood sample drawn at baseline and every 15 minutes for 1 hour, then every 20 minutes for the second hour. Two subjects did not complete the study and 4 subjects were poor/non-absorbers as the area under the glucose-time curve was negative. Therefore the data of the remaining 4 subjects was used.
As expected the control bread produced an increase in glucose in the normal subjects that reached a broad peak after 45 minutes. The peak glucose for the Phase 2® group occurred at 30 minutes. This dose of Phase 2® produced a smaller increase than the control from 15 to 80 minutes, with an almost significant difference (p < 0.1) at 45 and 60 minutes. The glucose cleared from the plasma about 30 minutes earlier with the Phaseolamin™ compared to the control. The area under the plasma glucose-time curve (a measure of glucose absorption and metabolism) was 85% lower with the Phase 2® , p < 0.05. Thus only 15% of the glucose in the bread compared to the control found its way into the body in the presence of Phase 2® . These results show the effectiveness of the product in decreasing the absorption of glucose from complex carbohydrates from this group of subjects.
Chart #1: Comparison of Phase 2® and Control on Change in Plasma Glucose in College-Age Subjects
Chart #2: Comparison of Phase 2® and Control on Change in Plasma Glucose in 11 Subjects

In vivo effectiveness of a starch absorption blocker in a double-blind placebo-controlled study with normal subjects
Joe A. Vinson, PhD, Donna M. Shuta, BS and Hassan Al Kharrat, MS
Department of Chemistry
University of Scranton
Scranton, PA 18510

Analysis data were obtained from the first study done reported on September 6, 2001and the second study on November, 20, 2001. The total subjects from both studies numbered 20. Nine were excluded who did not furnish all blood samples or who had a negative area for the plasma glucose-time curve and were therefore poor absorbers.
Of the 11 subjects, 8 were female and 3 were male, ranging in age from 21 to 57. The Phase 2® group had significantly lower plasma glucose at 60 minutes and almost significantly lower glucose at 45 minutes. The area of the curve (area above the baseline which is 0 to 62 minutes for Phase 2® and 0 to 80 minutes for the control), which represents glucose absorption and metabolism, was 66% smaller with Phase 2® .
This product shows effectiveness in both sedentary college-age subjects and physically active adults.

Effect of chronic amylase inhibition on pancreatic growth and acinar cell secretory function in rats.
Kataoka, K.; Dimagno, E. P.
JOURNAL NAME- Pancreas
VOL. 17
NO. 1
1998
PP. 50-56
ISSN- 0885-3177
AUTHOR AFFILIATION- Gastroenterol. Res. Unit, Mayo Clin., 200 First St. S.W., Rochester, MN 55905, USA
LITERARY INDICATOR(S)- RESEARCH ARTICLE
PRINT PRODUCT NUMBER- Biological Abstracts Vol. 105 Iss. 017 Ref. 241524
LANGUAGE- English NDN- 007-0674-2864-6

Wheat amylase inhibitor (WAI) was given to growing rats to determine whether chronic inhibition of intraluminal amylase activity alters pancreatic growth, pancreatic enzyme composition, and secretory responsiveness to cholecystokinin octapeptide (CCK-OP) and carbachol. For 21 days 13 rats were fed amylase inhibitor (Al) as 2.72% of the weight of their food; 13 were pair-fed controls (PFC), and 12 were controls with free access to food (FAC). Amylase and lipase secretion was measured from isolated pancreatic acini in response to CCK-OP (10-12-10-8 M) and carbachol (10-8-10-3 M). Al and PFC rats had similar food intakes and weight gains, pancreatic weights, and contents of enzymes (amylase, lipase, trypsin, chymotrypsin), protein, and RNA, but these measurements were significantly reduced compared to those of FAC rats. DNA contents per milligram of pancreas and per gram of body weight and amylase/DNA and trypsin/DNA were similar among all groups. Lipase/DNA and chymotrypsin/DNA in Al rats were the same as in PFC rats but significantly lower than in FAC rats. In response to CCK-OP, amylase secretion was similar in all three groups, but in response to carbachol amylase secretion was significantly less in AI compared to PFC and FAC rats. Lipase secretion increased in response to CCK-OP in Al compared to PFC and FAC rats but was similar in all three groups in response to carbachol. Long-term inhibition of intraluminal amylase activity suppresses pancreatic growth and content of enzymes and RNA by reducing food intake and weight gain and also decreases acinar cell secretion of amylase in response to carbachol and increases lipase secretion in response to CCK-OP.

Prevention of hypoglycaemia in a patient with type Ib glycogen storage disease by an amylase (alpha-glucosidase) inhibitor.
Ihara, K.; Kuromaru, R.; Ryu, A.; Fukushige, J.; Hara, T.
JOURNAL NAME- Acta Paediatrica
VOL. 87
NO. 5
1998
PP. 595-598
ISSN- 0803-5253
AUTHOR AFFILIATION- Dep. Paediatr., Fac. Med., Kyushu Univ., 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
PRINT PRODUCT NUMBER- Biological Abstracts Vol. 105 Iss. 015 Ref. 219968
LANGUAGE- English NDN- 007-0670-7358-3

Patients with type Ib glycogen storage disease (GSD Ib) are susceptible to hypoglycaemic episodes. To determine whether an amylase (alpha-glucosidase) inhibitor, voglibose, can be useful in the control of hypoglycaemia, we tried it in a 14-y-old male with GSD Ib. Oral administration of voglibose prolonged the duration of normoglycaemia and reduced the incidence of hypoglycaemia attacks. These findings indicate that voglibose may be useful for preventing hypoglycaemia in GSD Ib patients.

Effect of a wheat amylase inhibitor on canine carbohydrate digestion, gastrointestinal function, and pancreatic growth.
Koike, D.; Yamadera, K.; Dimagno, E. P.
JOURNAL NAME- Gastroenterology
VOL. 108
NO. 4
1995
PP. 1221-1229
ISSN- 0016-5085
AUTHOR AFFILIATION- Gastrointestinal Res. Unit, Mayo Clin., 200 First St. SW, Rochester, MN 55905, USA
LITERARY INDICATOR(S)- RESEARCH ARTICLE
PRINT PRODUCT NUMBER- Biological Abstracts Vol. 099 Iss. 011 Ref. 154668
LANGUAGE- English NDN- 007-0494-2573-4

Background/Aims: Chronic amylase inhibition might be useful to treat diabetes mellitus and obesity. Duodenal and ileal cannulas were placed in 8 dogs to determine if long-term ingestion of a wheat amylase inhibitor maintained amylase inhibition or affected gastrointestinal or metabolic function or pancreatic growth. Methods: Five dogs were fed and 3 were not fed 1.5 g of the inhibitor with meals for 9 weeks. Postprandial and cholecystokinin octapeptide stimulated pancreatic secretion, and fecal balance studies were performed at intervals. After the experiment, the pancreas was analyzed. Results: Weight loss was similar in both groups. Amylase inhibition persisted throughout the 9 weeks; it declined from 91% to 37% from the first to the sixth postprandial hour. Amylase inhibition decreased plasma glucose levels during the first hour (P lt 0.05), increased carbohydrate delivery to the ileum (3.5 vs. 555 mg/h; P = 0.002), and increased cholecystokinin octapeptide-stimulated amylase secretion. However, amylase inhibition did not significantly change plasma concentrations of insulin, peptide W or neurotensin, postprandial pancreatic secretion, gastrointestinal transit or pancreatic weight, and protein or DNA content. Conclusions: Prandial ingestion of 1.5 g of the inhibitor for 9 weeks reduces postprandial amylase levels enough to delay carbohydrate digestion and absorption and lower plasma glucose levels without altering pancreatic growth. This dose may be effective to treat diabetes mellitus but not obesity.