Good stuff Wilson6.
From another perspective, not only is it "pure unadulterated virgin bullshit ", but if it WERE true, or even if they told the truth (that phaseolamin blocks INTESTNAL digestion of SOME starches), then you would find that people who ate a lot of beans would never get fat! This clearly absurd, and also ignores that these inhibitors of amylase are found in almost all legumes and grains. So by their logic, carbs from grains and legumes can't be absorbed so you can eat all of them you want without adding calories to your diet LOL.
Here's more "food for thought" from a preliminary court case against a distributor/marketer of this stuff:
11. Before examining several studies that have been conducted to determine whether starch blockers are effective in man, certain facts should be noted which
militate against a finding of efficacy:
(a) First, the pancreas produce an abundance of alpha-amylase and only 4% of that which is produced is necessary to cause the digestion of large amounts of starch.
2/ Thus, even if it were assumed that Starch Block was an effective inhibitor of amylase in the human body, the product would have no effect upon the digestion of
starch unless it were capable of inhibiting more than 96% of the amylase produced. It is the opinion of Dr. Hashim that such a result is not possible because the
pancreas are constantly producing amylase each time a person swallows and the Respondent's product would literally have to "sit there and wait" for all of the
amylase to come down from the pancreas. (Tr. 354-356). Dr. Hashim's views are consistent with the consensus of informed medical opinion. (Tr. 398).
(b) It has been noted that the pH optimum for inhibition of amylase is 5.5 in test tube studies and that an incubation period of 20 minutes (for the inhibitor to
inactivate the starch-splitting enzyme) is also required. In light of this, the Carlson study (Exh. C-12, p. 394) stated, and I find, that "intraluminal conditions are clearly
not favorable for optimum inhibition." (See also Exh. C-10, p. 1415).
(c) Finally, three studies have speculated that "starch blockers" would be inactivated by gastric acid, pepsin or pancreatic proteases. (Exhs. C-10, C-12, and C-13).
12. When amylase has been completely removed from the body, as in the case of a person who has had his pancreas removed, then the ingestion of starch results in
abdominal distension, cramping, abdominal pain, diarrhea, foul-smelling stools, and anal irritation. Varying degrees of amylase inhibition in a normal person would
produce varying degrees of these symptoms. (Tr. 353).
13. Bo-Linn Studies. Several studies have been published which conclude that starch blocker tablets do not inhibit the digestion and absorption of starch calories in
human beings. The first of these studies appeared in the December 2, 1982 issue of The New England Journal of Medicine. The study is entitled "Starch
Blockers--Their Effect on Calorie Absorption from a High-Starch Meal" and was conducted by George W. Bo-Linn, M.D., John S. Fordtran, M.D. and two
associates. The New England Journal of Medicine is a distinguished, widely disseminated publication and articles appearing therein are subjected to a rigorous peer
review system (Tr. 359-360, 178). Dr. Fordtran is one of the outstanding investigators in the field of gastroenterology and has an outstanding laboratory and an
international reputation. (Tr. 181, 189). Briefly stated, they used a one-day calorie-balance technique and a high-starch (100 gram) mean (spaghetti, tomato sauce,
and bread), that measured the excretion of fecal calories after normal subjects had taken either placebo or starch blocker tablets. If the starch blocker tablets had
prevented the digestion of starch, fecal calorie excretion should have increased by 400 calories. However, fecal calorie excretion was the same on the two test days.
(Exh. C-10).
14. The one-day calorie-balance technique begins with a preparatory washout in which the entire gastrointestinal tract is cleansed of all food and fecal material by
lavage. After four hours, the subject then eats the test meal. Test meals are prepared in duplicate with one consumed in its entirety by the subject and the other
analyzed for calorie content in a bomb calorimeter. After eating the test meal, the subject did not eat or drink for fourteen hours. The entire gastrointestinal tract was
then cleansed again by lavage. The rectal effluent from the latter process was then tested for calorie content in a bomb calorimeter to reveal the number of calories
absorbed.
15. The above procedure was carried out with five subjects on two separate test days --on one with starch blocker tablets and on the other with placebo tablets.
The order of the test days was randomized. On the day of the starch blocker test the subject ingested two commercially available starch blocker tablets immediately
before beginning to eat the test meal. Each of the tablets contained 500 milligrams of the amylase inhibitor phaseolamin. When the subject had eaten half the meal, he
or she took another starch-blocker tablet. The branch of starch blocker tablets chosen for this experiment have been shown by in vitro tests to produce the required
antiamylase activity. Placebo tablets were ingested along with the test meal on the other test day. (Exh. C-10).
16. If the starch blocker tablets in the Bo-Linn study had been effective in vivo, they should have increased fecal calorie excretion by 388 calories after the subjects
ate the high starch meal. However, the study revealed that fecal calorie output was not higher after ingestion of the starch blocker tablets than after the placebo. It
was concluded that the starch blocker tablets did not inhibit the digestion and absorption of starch in vivo. (Exh. C-10).
17. The scientific methodology of the Bo-Linn test was sound. (Tr. 359). Complainant's highly experienced expert, Dr. Hashim, has had a great deal of experience
with bomb calorimetery and thinks highly of it. (Tr. 361-362). This is so even though he recognizes that bomb calorimetery does not measure 100% of the calories
absorbed since some are converted into gas which cannot be detected by that method. (Tr. 430). He has no problems with this study. (Tr. 363).
(a) The lavage technique is a routine procedure for cleansing the G. I. Tract. (Tr. 179-180). The use of lavage in combination with a bomb calorimeter, however, is
new. (Tr. 424). Dr. Hashim recognizes that when food is present in the system the lavage method tends to cause the production of about 5% more amylase than
normal (Tr. 427) because the food and electrolyte solution stimulates the vagus nerve. (Tr. 300). But this does not invalidate the study, because the lavage performed
in the presence of food was done long after the meal was ingested, and any remaining digestive process would then be occurring in the colon rather than the upper
part of the small intestine where amylase activity exists. (Tr. 300-301). This methodology was scientifically sound. (Tr. 359). 3/
18. Subsequently, Dr. Bo-Linn conducted the same study (with two changes discussed below) using Respondent's Advantage Starch Block tablets. (Exh. C-15). As
in the previous study, Bo-Linn found that fecal calorie excretions were similar regardless of whether the subjects took Respondent's tablets or a placebo. He
concluded that Advantage Starch Block tablets do not inhibit the digestion and absorption of starch calories in human beings.
(a) This study differed from Bo-Linn's first study in two ways: (1) the second study used only three subjects instead of the five previously used; and (2) the second
study added ten grams of polyethylene glycol ("PEG") to the meal as a nonabsorbable marker. Dr. Fordtran, a co-author of both Bo-Linn studies, has previously
indicated that the use of ten grams of PEG per liter could influence the result of an experiment. (Exh. R-12, p. 38). PEG inhibits the absorption of sodium, and the
absorption of glucose in man is dependent on sodium. (Tr. 653). Although the second Bo-Linn study used ten grams of PEG in the meal, there is no evidence of
record as to the resulting concentration per liter. (Tr. 661).
(b) There was no statistically significant difference between the fecal calorie excretions from the Starch Block group and the placebo group. (Tr. 363). Also, the fact
that the standard deviation from the mean in the second study was much greater than the one in the first study is not meaningful because the later study only had three
subjects. (Tr. 438).
19. The Carlson Study. S. C. Johnson & Son, Inc. (Johnson's Wax) of Racine, Wisconsin, was interested in the possibility of marketing a starch blocker
preparation. (Tr. 217). This company, in collaboration with the Gastroenterology Laboratory of the Middleton Memorial VA Hospital and the Center for Health
Sciences of the University of Wisconsin, sponsored an experiment to determine the efficacy of starch blockers inhibiting starch digestion. The study was conducted
by Gerald L. Carlson, Paul Bass, Ph.D., and two other investigators. The study was reported (Exh. C-12) in the January 28, 1983, issue of Science, which is a very
highly regarded, peer reviewed publication. (Tr. 221). Dr. Bass teaches at the University of Wisconsin School of Medicine and the School of Pharmacology where
he specializes in the gastrointestinal tract. He is an expert with regard to the action of enzymes in the body. (Tr. 219-220).
(a) It is undisputed that effective inhibition of starch digestion in vivo would diminish glucose formation and absorption by the small intestine and increase the amount
of undigested starch reaching the colon. The Carlson study tested the effect of starch blockers made from Great Northern White kidney beans on glucose formation
and absorption by measuring changes in the concentration of glucose and insulin in the blood serum of human volunteers after they had consumed a starch meal. It
simultaneously measured breath hydrogen levels --these would rise if greater than 6 to 10 grams of unabsorbed carbohydrates reached the colon. If the product was
effective, the authors would have expected a reduced increase in glucose and insulin and elevated breath hydrogen production.
(b) Six subjects were tested on two occasions. The study was initiated in the early morning after a ten hour overnight fast. Baseline breath hydrogen samples and
blood samples for determination of glucose and insulin concentrations were taken prior to a prescribed high starch test meal. The alpha-amylase inhibitor product or
the placebo was crushed to a powder and homogenized with the meal prior to consumption. After the meal, blood samples were taken at 15, 30, 60, 90, 120, 150,
180, and 240 minutes. Breath hydrogen samples were taken every 15 minutes for six hours after meal consumption. The process was repeated seven days later
except that those who received starch blocker in the first meal received placebo on the second day and vice versa. In this way each subject acted as his own control.
(c) Using standard statistical methods, the study reported that there were no significant differences between the starch and placebo subjects. Breath hydrogen results
were similarly analyzed and revealed no inhibitory effect. The study concluded that formulations of the kidney bean-derived alpha-amylase inhibitor do not alter the
digestion of cooked starch in humans. (Exh. C-12).
(d) The Carlson study represents a scientifically valid approach to determine the efficacy of starch blockers. (Tr. 368). The six subjects who were tested represented
a sufficient number for the study. In this regard the number of subjects required depends upon the variability of the measurements one is making; this study had very
objective measurements. (Tr. 229). It is also noted that the use of different time intervals for the taking of blood samples would have yielded results very similar to
those obtained by the authors. (Tr. 249).
(e) The fact that the product was ground up and blended with the diet, rather than administered in tablet form, may have made it easier for the enzymes in the
stomach to deactivate the amylase inhibitor. (Tr. 798-799). However, this is counterbalanced by the fact that when the ground tablet is well-mixed with food, then
the food serves as a capsule to delay interaction with stomach acid. (Tr. 820).
20. The Garrow Study. The efficacy of starch blockers has been tested by another method by Dr. J. S. Garrow. The latter has a reputable nutrition laboratory under
the auspices of the National Research Council of Britain, and is personally known and respected by Complainant's expert, Dr. Hashim. (Tr. 369). Dr. Garrow's
study was published as a letter to the editor in the January "1/8," 1983, issue of The Lancet. (Exh. C-13). The Lancet is a clinical journal published in England which
is highly respected by general practitioners; however, its letters to the editor are not subjected to peer review. (Tr. 775-776, 202).
(a) Dr. Garrow's study tested starch blockers made from red kidney beans which had been shown to inhibit amylase activity in the test tube. The digestion of starch
can be measured by analyzing the amount of carbon dioxide in breath samples taken before and after a test meal. This is done by "labeling" the test meal of starch
with Carbon 13. Normally the carbon dioxide in expired air is maximally labeled with Carbon 13 about three hours after the meal, and about 30% of the ingested
Carbon 13 is oxidized to carbon dioxide within six hours of the meal. If starch blockers totally inhibit the digestion of starch, breath samples would not contain
Carbon 13, i.e., no labeling of expired carbon dioxide with Carbon 13 should be observed.
(b) Dr. Garrow tested five obese women on three occasions after an overnight fast with a meal containing "corn flour in the form of a blancmange flavoured with
lemon." 4/ Ten minutes before the meal, in random sequence, a starch blocker tablet or a placebo tablet (Gelusil) was ingested. For 30 minutes before the meal and
six hours after the meal, the metabolic rate and rate of carbon dioxide production were measured. Breath samples were taken for analysis of the labeled carbon
dioxide on three occasions before the meal and every half hour after the meal for six hours. It was found that the average percentage of carbohydrate meal oxidized
was not significantly different when the placebo group was compared with the two starch blocker groups. Moreover, there was no significant difference in the rates
of oxidation between the two groups. It was concluded that starch blocker tablets failed to delay either the digestion or further metabolism of the starch to any
measurable extent. 5/
(c) Since Gelusil is a pharmaceutically active substance which affects digestion, it would have been preferable for Dr. Garrow to have used another kind of placebo.
(Tr. 296). However, there is no evidence of record indicating what kind of effect, if any, Gelusil might have had on the findings of this experiment.
21. Another study was conducted by Dr. Bjontorp, a professor of medicine with an obesity clinic in Sweden. He gave starch blockers to a series of obese human
subjects and compared them with a placebo group on the basis of weight alone. He found no difference between the starch blockers and the placebo on body
weight. (Tr. 375).
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