Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-09-03
2004-08-17
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S023000, C514S054000, C514S060000, C426S658000, C426S661000, C426S804000
Reexamination Certificate
active
06777397
ABSTRACT:
FEDERALLY SPONSORED RESEARCH
Not applicable.
SEQUENCE LISTING OR PROGRAM
Not applicable
BACKGROUND
1. Field of Invention
This invention relates to mixtures of sugars useful for reducing caloric intake and glycemic index
2. Prior Art
Americans' rapidly increasing consumption of added sugars over the last fifteen years has contributed significantly to a major public health problem, the reversal of which the US Center for Disease Control and Prevention (Koplan and Fleming, J Am Med Assn, 284, 1696, 2000) has targeted as one of its ‘top ten’ health goals for the 21
st
century. The problem is the epidemic of obesity in the US. Obesity is defined as a body weight 30% above the ideal body weight Obesity is strongly linked with greater risk of heart disease, high cholesterol and blood pressure, type 2 diabetes, stroke and breast, colon and prostate cancers. A recent study has shown that more than 50% of Americans are overweight, and 22% are obese.
Over the 8-year period from 1991 to 1999, obesity among American adults rose from 12.0% to 18.9%, an increase of 57%. Coincident with the rise in obesity came a 33% increase in type 2 diabetes (from 4.9% to 6.5% overall) In a Reuters news article, dated Jan. 26, 2001, Dr. Ali Mokdad of the CDC's National Center for Chronic Disease Prevention and Health Promotion was quoted as saying, “We've seen a tremendous increase in obesity in the 90′s—that's why we're now seeing an increase in diabetes.” He went on to say, “Obesity is no longer a cosmetic issue, but a risk factor for serious illness We need to change our behaviors to reduce many of the chronic diseases we are facing, not only diabetes.”
The average American now consumes more than 80 grams of added sugars (typically as sucrose, glucose and fructose) each day. Added sugars are those sugars that are incorporated by man into processed foods and beverages, and do not include sugars that are naturally present in the natural and processed foods that we eat. Over the 8-year period from 1991 to 1999, adult consumption of added sugars rose from 70 to 80 grams/day while consumption of fat (and presumably protein) remained fairly constant. The average adult body weight over the same time period increased 2.9 lb, from 166.5 lb to 169.4 lb. We assume a constant level of activity for the adult over the 8-year period. Then, the increased consumption of added sugars (10 grams/day×3.9 kcal/gram=39 kcal/day vs an average 2000-kcal/day diet) alone can account for 3.2 lb, or all of the body weight increase observed over the 8-year span. Clearly, added sugars are important in controlling unwanted weight gain in adults.
The US Department of Agriculture recommends that an adult who eats a 2000-kcal/day healthful diet should try to limit himself or herself to consumption of about 40 grams of added sugars per day, or 8% of total caloric intake. This level of consumption is ½ of the current level of added sugars, with ½ of the associated calories. The subject invention allows one to continue consuming 80 grams of added sugars per day, but with no more than the caloric intake of the USDA-recommended 40 grams per day of added sugars. The subject invention, in addition, allows one to consume the same sugars that have gained acceptability (e.g. safety, quality of taste, ease of use in foods, and low cost) for many decades without exposure to any new or rare carbohydrates, carbohydrate derivatives, rare plant extracts, or artificial sweeteners.
Fructose, lactose and sucrose are widely consumed natural sugars in the American human diet (37, 16 and 81 grams/capita/day, respectively). All are known to be fully caloric (i.e., approximately 4 kcal/gram) when used separately in typical foods. It is known that ingestion of any of the three cited sugars as part of diet does not interfere with absorption of glucose, protein, or lipid from the small intestine. In fact, no report of any interaction of fructose, lactose, or sucrose with other human dietary components to reduce caloric utilization or raise glucose tolerance in animals or man has been reported previously. It is widely known (Wolever, 1995) that fructose has a substantially lower glycemic index (23) than lactose (46), sucrose (61 to 64), glucose (100), or oat starch (100). Because of their low glycemic indexes, fructose and lactose separately have been posed as useful for diabetics (Wolever et al, 1985 and Wolever et al, 1995), but no synergy between the two sugars or with other sugars has previously been disclosed that would suggest lower-than-expected glycemic indices or reduced caloric utilizations.
With the aforementioned facts about the three subject sugars in mind, the literature reveals prior art in the field of carbohydrate utilization. Eleven animal studies conducted over the past eight decades have shown inconsistent results, which bear on the apparent caloric value of lactose. The results from rats and pigs, the only two animals reported, were not always consistent with human results
For example, Whittier et al (1935), Tomarelli et al (1960), and Baker et al (1967) studied the effect of lactose (30%, 52%, and 50% of diet, respectively) with glucose in pair-fed and ad libitum diet as the only two sources of carbohydrate in growing rats' diet, as compared to sucrose or glucose in control diet. All three research groups found lower body weight and body fat in the ad libitum-lactose-fed, sacrificed rats. Pair-fed rats showed the same body weight but lower body fat for lactose vs controls (down 38%, 40%, and 48% respectively). Whittier et al confirmed the lower fat weight effect in pigs fed restricted diets including lactose and brewers' yeast and even found increased longevity in rats fed lactose. Tomarelli et al attributed the observed fat-sparing effect of lactose largely to bacterial action of the disaccharide in the cecum. Similar reduced body fat weights were observed in rats fed sorbitol, cellobiose, and raw potato starch (resistant starch), all of which are poorly absorbed carbohydrates that undergo bacterial degradation in the cecum. The authors noted in exploratory experiments the blood glucose levels of rats fed glucose and lactose diets were not significantly different Baker et al found a greater hypolipogenic effect with the &bgr;-anomer of lactose than with the &agr;-anomer
Février (1969) studied the effect of lactose (30% of diet) with corn starch (32.7% of diet) as the only sources of carbohydrate in ad libitum, pair-fed, and equal-growth diets in growing rats, as compared to a starch (62.7%) control. Ad libitum feeding resulted in a 37% reduction of growth rate and 20% reduction of fat content for the lactose-fed rats. Pair-feeding resulted in a 23% reduction of growth rate and 32% reduction of fat content for the lactose-fed rats. Equalized-growth-feeding resulted in a 12% reduction of fat content for the lactose-fed rats. The author asserted that the cause of the body fat reduction was the lower metabolizable energy of the lactose and a loss of galactose in the urine.
Dalderup et al (1969) reported that adult male rats fed 15 calorie % lactose in potato and bread starch diet over four months excreted a significantly larger amount of feces and formed a larger amount of lactic acid in feces compared with a 15-calorie % glucose group. These two observations support the notion that lactose in rats is not well-absorbed in the small intestine and is fermented in the cecum and/or colon.
Ali and Evans (1971) studied the growth of weanling male rats fed ad libitum “equicaloric” diets containing either 0 or 12% lactose over a six-week period. The basal diet included 30% starch and 30% sucrose. Lactose was added to the basal diet at the expense of part of the sucrose The work was directed to study effects and interactions of dietary lactose and other dietary components on gross body composition in the growing rat, by multi-variable regression analysis. Lactose did not have any effect on diet consumption or body protein vs basal diet The most pronounced effects were those of lactose o
Zehner Lee R
Zehner Warren L.
McDermott & Will & Emery
McIntosh III Traviss C.
Vivalac, Inc.
Wilson James O.
LandOfFree
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