Double-Blind Study of the Safety and Efficacy of Fattache® Dietary Supplement


RESULTS OF: CLINICAL STUDY PROTOCOL No. 97-002

SPONSORS:
Herbal Sensations 3326 Mary Street Coconut Grove, Florida 33131

August 15, 1998

Abstract

Background
Fattache® is a commercially available dietary supplement designed to bind dietary fats for weight reduction. The active ingredients of Fattache® include, chitosan, apple pectin, plantago ovata seed, glucosamine and glucomannan, Chitosan, a derivative of chitin, has been described as the second most abundant natural Biopolymer, cellulose being the first. As a natural occurring fiber, chitosan is thought to block the absorption of dietary fat in the gastrointestinal tract. The Lipid binding properties of chitosan have been studied extensively in laboratory animal and minimally in humans. We conducted a double-blind, placebo controlled study to determine the efficacy of Fattache® on dietary fat binding and weight loss. In addition to efficacy variables, we sought to further define the safety profile of Fattache®. This clinical trial is a follow-up study to a 10 patient open-label study completed on April 15, 1997.

Methods
In a Double-Blind placebo controlled trial, fecal fat content, body weight, blood pressure, and fasting lipid profiles were evaluated before and after thirty days of treatment with Fattache®. Following the double-blind period, all patients received active treatment, in an open-label fashion for sixty additional days. Our patient population consisted of 37 mildly to moderate obese, healthy volunteers. In all, this study was conducted over a 90 day period in Mobile, Alabama.

Results
After only four weeks of treatment Fattache® did have a statistically significant positive weight reduction. The average weight loss in the treatment group was -3.63 pounds versus a 2.31pound weight gain in the placebo group. This weight reduction was associated with a corresponding statistically significant increase in fecal fat content in the treatment group versus the placebo group. Lastly, but perhaps most compelling, were the positive results on the lipid profiles seen in the Fattache® treatment group. High-density lipoproteins or HDL’s (“the good cholesterol”) were increased by an average of 4.95mg/dl in the treatment group while the placebo group experienced a -4.61mg/dl decrease. The low-density lipoproteins or LDL’s were decreased by and average of -11.72mg/dl in the treatment group and increased by 14.21mg/dl in the placebo group. Total cholesterol was decreased by ·11.05mg/dl in the treatment group and increased by 20.17mg/dl in the placebo group. The long-term, open-label arm of this study also showed positive weight loss and lipid profile results and are discussed herein. No statistically significant difference was seen between the two treatment groups on diastolic or systolic blood pressure measurements. No significant adverse events, associated with Fattache® were reported.

Conclusion
The positive results of this double-blind, placebo-controlled study lead us to conclude that Fattache® is a safe and effective fiber supplement for dietary fat binding and weight loss. Patients experienced a gradual weight loss in lieu of strict dietary restrictions. The lipid profile findings are also promising and suggest benefits of Fattache ‘® as a natural occurring lipid lowering agent irrespective of weight loss.

Introduction

Obesity has reached endemic proportions in the United States. Sixty-eight percent of all Americans are considered overweight and 34% of these are considered obese Forty-two percent of the calories consumed in an American diet consist of fat. The American Heart Association recommends dietary fat intake be maintained at 20% or less of total calories. Currently, on an average day, Americans ingest 40% of total calories as fat.

Increasing weight and obesity in combination with smoking habits, minimal or no physical activity, and poor dietary food chokes have strongly contributed to increased levels of blood lipids and ultimately cardiovascular morbidity and mortality. Thus, any safe dietary supplement with the capacity to lower serum lipids and reduce weight is worth further clinical investigation.

Recently, the use of modified dietary therapy and adjunctive drug therapy has been recommended to achieve desirable reductions in weight and lipid levels. To date, prescription drug therapy has been restricted to severe hypercholesterolemia due to safety concerns inherent in long-term drug therapy. Thus, the positive weight and lipid profile results derived from consistent supplementation with natural occurring fibers have gained in public and scientific interest. In fact, chitosan, psyllium seed, pectin, glucomannan, and guar gum are readily available and commonly recommended by physicians and nutritionist alike to treat mild to moderate hypercholesterolemia.

CHITOSAN
Chitosan, a natural fibrous material is found in the exoskeletons of crustaceans, or more commonly known as shellfish. Chemically, chitosan is a polymer primarily formed by repeating units of K-acetylglucosamine. Its structure is similar to cellulose except these groups are deacetylated. Chitosan is a polysaccharide formed mainly of repeating units of D-glucosamine.

Unlike most polysaccharides, chitosan has a positive charge. At acidic PH, the amino acid groups take on hydrogen ions resulting in overall positive charge to the polymer. Due to this positive charge, negatively charged molecules can be attracted to these sights and be ionically bound to chitosan. Examples of negatively charged molecules include free fatty acids, bile acids, and others. Chitosan with bound lipids are then excreted in the feces.

Furthermore, Chitosan as a solid formulation has the ability to also bind neutral lipids in vivo such as triglycerides, cholesterol and other dietary sterols. Previous animal trials conducted in Norway showed excellent reducing efficacy of serum cholesterol and serum triglyceride levels in the blood, while HDL fraction of cholesterol increased.

A four week, double-blind, placebo controlled trial of 30 average to moderately obese patients was conducted in Helsinki, Finland (October, 1994) to determine the weight and blood pressure reduction of chitosan. In addition to receiving either chitosan or Placebo, patients were placed on a 950-1000 kcal/day diet. The results showed no adverse events (in fact most mild, transient side effects were seen in the placebo group) excellent compliance in the treatment group (no dropouts occurred), average weight reduction of 8% in the treatment group and a decrease of blood pressure of 19.8 mmHg systolic and 8.9 mmHg diastolic in the treatment group.

Toxic effects have only been studied in Sprague-Dawley rats to date. Massive and continuous chitosan feeding (10% of total dietary intake) for two weeks caused a decrease in mineral absorption, bone mineral content and serum vitamin E content. From this, it is recommended that fat-soluble vitamins be supplemented daily, at least 2 hours after ingestion of chitosan. Chitosan is considered safe to use and falls under the FDA guidelines for a natural fiber.

Given that chitosan is a fiber and other fibers can pull dietary fat from the body, some researchers wondered if there was really anything special about chitosan. Four Japanese scientists used laboratory animals to compare the effects of chitosan to 22 other fibers, including pectin, guar, carrageen, and others that have been used for weight loss. The researchers concluded that chitosan, unlike other fibers studied, and markedly increased the fecal fat excretion.

The tremendous potential of chitinous polymers for numerous applications has received limited recognition in the past. However, a significant amount of fundamental animal research on chitin and chitosans have been carried out since chitin was first described more than 180 years ago.

PSYLLIUM (PLANTAGO OVATA)
Recently, the Food and Drug Administration (FDA), has announced its decision to authorize the use, on food label and in food labeling, of health claims on the association between soluble fiber from psyllium seed husk and reduced risk of coronary artery disease. Based on its review of evidence submitted, the agency has concluded that soluble fiber from psyllium seed husk may reduce the risk of coronary artery disease by lowering blood cholesterol levels. The agency has concluded, based on the totally of scientific evidence, that there is significant agreement among qualified experts to support the relationship between soluble fiber in psyllium and coronary artery disease. The FDA defines psyllium seed husk as the dried seed coat (epidermis) of the seed of plantago ovata.

PECTIN
Pectin, guar gum, and psyllium have been shown to lower plasma low-density lipoprotein. (LDL) cholesterol concentrations in guinea pigs with different orders of magnitude by inducing defined alterations in hepatic cholesterol homeostasis. Dietary pectin was fed with physiological low cholesterol, or pharmacological high cholesterol diets to assess whether cholesterol intake influences plasma LDL lowering mechanisms. Intake of pectin with low cholesterol or high cholesterol diets lowered plasma and hepatic cholesterol concentrations. Pectin and psyllium up-regulated 7∞ hydroxylase activity by 3-fold in the low cholesterol diet group and by 5-fold in the high cholesterol diet group. In contrast, guar gum intake had no effect on 7-∞hydroxylase activities. In addition, cholesterol absorption was reduced by 30% in the pectin intake.

GLUCOMANNAN
A study designed to determine the clinical use of glucomannan and its effects on blood glucose and cholesterol in obese and non-obese diabetics was conducted in 1990. A total of 195 NlDDM patients were randomly enrolled in the study. The patients were grouped according to the type of diabetic management diet alone, oral sulphonylurea and insulin groups. All patients took 7.8 grams of glucomannan daily for 16 weeks. Mean cholesterol levels were reduced in both obese and non-obese diabetics in all groups.
Mean triglyceride levels were reduced only in the obese diabetics in the diet and insulin groups. Significant reductions in blood glucose and body weight were found in obese diabetics receiving glucomannan.

FATTACHE®
Fattache® is a new; non-prescription, commercially available compound that maybe extremely useful as an “everyday” dietary supplement. Fattache® contains chitosan, plantago ovate or psyllium seed, apple pectin, glucosamine and glucomannan.

Recently, a pilot study of Fattache® was completed. This study was designed to measure fecal fat content, weight, lipid profiles and blood pressure before and after treatment. After four weeks of treatment, Fattache® did have a positive weight reducing effect with an average weight loss of 1% of body weight. In addition, fecal fat increased by 5.5%, and HDLs increased by an average of 2.lmg/dl. While these results are not as robust as the Helsinki trial, patients in the pilot study were of normal weigh to mildly obese and maintained their normal daily caloric intake. In the Helsinki trial, study participants were restricted to a 950-1000 kcal/day diet. However, before definitive statements and recommendations regarding the use of Fattache® can be made, clinical studies involving mildly to morbidly obese patients should be conducted in a double­ blind fashion.

Thus, a double-blind, placebo controlled study designed to measure weight, fecal fat content, lipid profiles, and blood pressure before and after 30 days of treatment with Fattache® or placebo in 37 mildly to moderately obese patients was conducted. Following he initial 30 day double-blind period, all patients were treated with Fattache® for an additional 60 days in an open-label fashion.

Objectives

The primary objective of the study was to demonstrate that Fattache® reduced body weight, increased fecal fat content, normalized blood pressure and improved lipid profiles compared to placebo. The secondary objective of the study were to determine the long term safety and efficacy of Fattache®.

Study Design

This double-blind, placebo controlled study was conducted in 37 mild to moderately obese (5% to 15% above average body weight) subjects. Eighteen patients received placebo and 19 patients received active treatment with 500mg capsules of Fattache® for an initial 30-day period. Following the initial Double-blind period, all patients received active treatment with Fattache® for an additional 60 days in an open-label fashion.
Eligible patient, meeting all inclusion and exclusion criteria, were consented and then randomized to treatment group A or B, according to the randomization table shown below (table 1). All baseline measurements were repeated on day 30. On days 60 and 90, weight, blood pressure, serum lipids a complete blood count and urinalysis were performed for long-term safety and efficacy.

All subjects were dispensed Fattache® or placebo (first 30 days only for group A) at regular intervals and instructed to take four capsules twice daily with their largest meals. The participants were also asked to drink 8 to 10, 8 ounces glasses of water daily and to continue all normal dietary habits (strict dieting was prohibited). Each patient completed daily dietary food charts. Compliance with all study related procedures were strictly monitored.

Inclusion and Exclusion Criteria

In order to be enrolled in the study, the patient s had to be female, 18 to 76 years of age, sign a written informed consent, and be 5 % to 15 % above average body, weight for gender, height and body type. Eligibility weight percentiles were based on the 1993 Metropolitan Height-Weight Tables. Patients were excluded from the study if they were pregnant or breast feeding, had a history of any disabling disease or had an allergy to shellfish or pectin containing products.

Study Procedures

Screening
The principal investigator assessed the eligibility for the study entry after a complete medical history and the study physician completed a physical examination. Safety labs, including a complete blood count, urinalysis and urine pregnancy test were obtained.

Baseline (Study Day 1)
Prior to initiation of Fattache ® or placebo, a full fasting lipid profile and a 72 hours stool sample for quantitative fecal fat were collected. Routine vital signs were measured and recorded. A seven day supply of Fattache® or placebo was dispensed

Study Days 1 Through 90
Throughout the entire study, patients were instructed to take 4 capsules of study drug with the A.M. meal and 4 capsules with the P.M. meal. Each dose was to be taken with an 8ounce glass of water. Patients were also urged to drink 8 to 10, 8ounce glasses of water and complete daily food charts. Concomitant medications and adverse events were recorded.

Study Day 7 and 14
Patients were asked to return to the clinic for routine vital signs and study drug compliance and food chart completion. Study drug was again dispensed. All non­compliant patients were withdrawn from the study at this time. Compliance was based on percentage of study drug taken and completion of food charts.

Study Day 30 or Early Termination
Patients returned to the clinic for a final double-blind visit. The study physician completed a physical exam. A second fasting lipid profile and safety labs were obtained. A 72 hours stool sample for quantitative fecal fat was collected. Routine vital signs, including weight, were measured and recorded. Patients returned all completed food charts and unused study drug. A 30-day supply open-label Fattache® was dispensed to all patients.

Study Day 60 and 90
Patients returned to the clinic for open-label visits. The study physician completed a physical exam. A fasting lipid profile and safety labs were obtained. Routine vital signs, including weight, were measured and recorded. Patients returned all completed food charts and unused Fattache®.

Results

This study was designed to have 20 patients per treatment group complete a 30 day double-blind period followed by an additional 60 days of open-label treatment with Fattache®. Seven variables were measured at the beginning of the study and again on days 30 (double-blind comparator), 60 and 90. The variables were:

Body weight
Percent fecal fat
HDL (high density lipoprotein)
LDL (low density lipoprotein)
Total cholesterol
Blood pressure, systolic
Blood pressure, diastolic

Double-Blind Period

For each of the seven variables, change from baseline was analyzed (Day 30 – baseline). A One-Sample t-Test \vas used to test for significant change from baseline within the placebo group and within the Fattache® group. A Two-Sample t-Test was used to test for differences between the placebo and Fattache® groups. The Two-Sample t-Test assumes a normal distribution of data.

Normality was tested using the Shapiro-Wilk test. For example, if the Shapiro-Wilk probability was greater than 0.05, then the data was normally distributed and the one Sample and Two-Sample t-Tests were the correct tests to use. If the data were normally distributed then the Wilcoxon Rank-Sum test was used. All statistical analysis were done using the SAS system (version 6.11). Statistically significant results are summarized below (Table 2).

Body Weight
Body weight was measured twice during the double-blind period, once at the beginning of the study and a second time after 30 days of treatment with Fatttache’® or placebo. The average weight loss for the Fattache® group was -3.63 pounds, while the placebo group gained an average of 2.34 pounds (Figure 1). A statistically significant difference between the Fattache® and placebo group was confirmed (p>0001).

Fecal Fat Content (%)
Stool samples were collected twice during the double-blind period, once at the beginning of the study and a second time after 30 days of treatment with Fattache® or placebo. The amount of fat in each 72 hours stool sample was determined and percent fat was calculated. The Fattache® group experienced an average 2.48% increase in fecal fat content while the placebo group had an average decrease of -3 .73% in percent fecal fat. Fattache® did significantly increase percent fecal fat when compared to placebo (p>. 0002, Figure 2).

Fecal Fat Content (%)
Before and After Fattache® or Placebo

Low Density Lipoproteins (LDL)
Lipid profiles, including LDL’s were collected twice during the double-blind period, once at the beginning of the study and a second time after 30 day of treatment with Fattache® or placebo. The LDL’s in the Fattache® group decreased by an average of 11.72mg/dl. The LDL’s in the placebo group increased by an average of 14.21mg/dl. In this study, Fattache® significantly decreased low-density lipoproteins compared to placebo (p>0.0001, Figure 3).

Low Density Lipoproteins
Before and After Fattache® or Placebo

High Density Lipoproteins (HDL’s)
HDL’s were collected twice during the double-blind period, once at the beginning of the study and a second time after 30 days of treatment with Fattache® or placebo. The HDL’s in the Fattache® group increased by an average of 4.95mg/dl while the HDL’s in the placebo group decreased by an average of -4.61 mg/dl. In this study, Fattache® significantly increased low-density lipoproteins compared to placebo (p>.0001, Figure 4).

High Density Lipoproteins (HDL’s)
Before and After Fattache®

Total Cholesterol
Total cholesterol was measured twice during the double-blind period, once at the beginning of the study and a second time after 30 days of treatment with Fattache® or placebo. The Fattache® group experienced an average decrease of -11.05mg/dl in total cholesterol while the placebo group had an average increase of 20.17mg/dl. Fattache® significantly decreased total cholesterol compared to placebo in this study (p>.0001, Figure 5).

Total Cholesterol
Before and After Fattache® or Placebo

Open-Label Period

Sixty and 90-day data were collected for each variable, except percent fecal fat. Change from baseline was analyzed (Day 60-baseline and Day 90-baseline). The statistical analyses employed in the double-blind period were also utilized in the open-label period. However, an important distinction is that only group A received placebo for the first 30 days. Thus, by day 90, group A had received 30 days of placebo and 60 days of Fattache®; the Fattache® group, or group B, received all 90 days of active treatment. The results are summarized below (Table 3).

Low Density Lipoproteins (LDL’s)
For the open-label study, low-density lipoproteins (LDL’s) were measured at baseline, at the end of the double-blind period, on day 60 and on day 90. Patients that were treated with placebo for the first 30 days (group A) experienced an average increase in LDL’s of 14.21 mg/dl. After being crossed over to Fattache®, the group A patients had a decrease of -2.77mg/dl for an overall net increase of 11.44 mg/dl following 30 days of Fattache® (sixty days total in the study). After 60 days of Fattache® (90 days total in the study), the group A patients had a decrease in LDL of -9.01mg/dl for a total net gain of 5.20mg/dl. The average change in LDL ‘s from baseline for group B was a decrease of -11.72mg/dl after 30 days, a decrease of -14.92 after 60 days and a decrease of -15.30 after 90 days (Figure 7). A statistically significant difference between the two groups
was confirmed for day 30 and day 60 (p>0.0001-30 days; p>0.0003-60 days; p>0.22-90 days)

Low Density Lipoproteins
Open-Label Study: Group A versus Group B

High Density Lipoproteins (HDL’s)
For the open-label study, high-density lipoproteins (HDL’s) were measured at baseline, at the end of the double-blind period, on day 60 and on day 90. Patients that were treated with placebo for the first 30 days (group A) experienced an average decrease in the “good cholesterol” of -4.61mg/dl. After being crossed over to Fattache®, the group A patients had an increase of 5.44mg/dl for an overall net increase of 0.83 mg/dl following 30 days of Fattache® (sixty days total in the study). After 60 days of Fattache® (90 days total in the study), group A patients had an increase in HDL’s of 10.74mg/dl for a total net increase of 6.13mg/dl. The average change in HDL’s from baseline for group B was an increase in the “good cholesterol” of 4.95mg/dl after 30 days, an increase of 2.62mg/dl after 60 days and an increase of 4.4mg/dl after 90 days (Figure 8). A statistically significant difference between the two groups was confirmed for day 30 only (p>0.0001).

As expected, no statistical significant difference between the two groups was seen after the placebo group was crossed over and received Fattache®.

Total Cholesterol
For the open-label study, total cholesterol was measured at baseline, at the end of the double-blind period, on day 60 and on day 90. Patients that were treated with placebo for the first 30 days (group A) experienced an average increase of 20.17mg/dl. After being crossed over to Fattache®, the patients in group A had a decrease of -21.42mg/dl for an overall net decrease of -1.25mg/dl after 30 days of Fattache® (sixty days total in the study). After 60 days of Fattache® (90 days total in the study), group A patients had a decrease in total cholesterol of -35.03mg/dl for a total net decrease of -14.88mg/dl. The average change in total cholesterol from baseline for group B was a decrease of 11.05mg/dl after 30 days, a decrease of -12.33mg/dl after 60 days and a decrease of 4.64mg/dl after 90 days (Figure 9). A statistically significant difference between the two groups was confirmed for day 30 only (p>0.0001). No statistical significant difference between the two groups was seen after the placebo group was crossed over and received Fattache®.

Total Cholesterol
Open-Label Study: Group A versus Group B

Systolic Blood Pressure
For the open-label study, systolic blood pressures were measured at baseline at the end of the double-blind period, on day 60 and on day 90. Patients that were treated with Placebo for the first 30- days (group A) experienced an average decrease in systolic blood pressure of -1.94mmHg. After being crossed over to Fattache®, the group A patients had a negligible increase in systolic blood pressure after 30 days of Fattache® (sixty days total in the study). After 60 days of Fattache® (90 days total in the study), group A had a decrease in systolic blood pressure of -2.35mmHg for a total net decrease of -4.29mmHg. The average change in systolic blood pressure from baseline for group B, was a decrease of
-2.71mmHg after 30 days, a decrease of -2.27mmHg after 60 days and a decrease of -6.78mmHg after 90 days. A statistically significant difference between group A and group B was confirmed for day 30 only (p>0.0001). No statistical significant difference between the two groups was seen after the placebo group was crossed over and received Fattache®

Diastolic Blood Pressure
For the open-label study, diastolic blood pressures were measured at baseline, at the end of the double-blind period, on day 60 and on day 90. Patients that were treated with placebo for the first 30 days (group A) experienced an average decrease in diastolic blood pressure of 6.65mmHg. After being crossed over to Fattache®, group A patients had a decrease in diastolic blood pressure of -3.56mmHg after 30 days of Fattache® (sixty days total in the study). After 60 days of Fattache® (90 days total in the study), group A patients had a slight increase ·in diastolic blood pressure of 4.51mmHg for a total net decrease of -2.14mmHg. The average change in systolic blood pressure from baseline for group B was a decrease of -5.35mmHg after 30 days, a decrease of -9.08mmHg after 60 days and a decrease of -4.45mmHg after 90 days. No statistical significant difference between the two groups was seen throughout the entire study.

Adverse Events
At each visit, patients were asked if they experienced any side effects or adverse events. Only two patients experienced adverse events. One patient complained of headache and diarrhea while on Fattache®. This was described as mild and was determined to be possibly due to Fattache®. The headache and diarrhea completely resolved following discontinuation of the Fattache®. In addition, a rash was noticed on one patient. However, this patient was taking placebo when the rash occurred, thus this adverse event was not related to Fattache®.

Compliance
It was determined that 22 out of 37 patients took at least 90% of prescribed study drug, 31 of 37 patients took at least 80% of study drug, 35 of 37 patients took at least 70% of study drug while 2 patients had less than 70% compliance, 53% and 68% respectively. Percent compliance was verified by counting remaining pills in the returned containers.

As in the pilot study, the number one reason why study drug was omitted was due to missed meals. The patients elected not to take the study drug when a rare morning or evening meal was skipped. The patient that was only 53% compliant was randomized to the Fattache® group, gained 1.5 pounds after 30 days and dropped out of the study after 30 days. However, the patient that was only 68 % compliant lost 6 pounds after 90 days of treatment with Fattache®. Lastly, only 21 of 37 patients completed the entire 90 days of treatment. Specific reasons for patient dropouts are listed below in (table 4).

Discussion

This clinical investigation of Fattache® was undertaken because, to date, a great deal of animal data exists suggesting the importance of chitosan, psyllium seed, pectin, glucomannan in the treatment of obesity; the active ingredients in Fattache®. However, very little clinical data is available regarding the safety and effectiveness of natural occurring supplements in humans. Thus, scientists and consumers alike are forced to make clinical decision about weight loss and cholesterol lowering nutraceuticals through extrapolation from animal models.

The investigation was a double-blind, placebo-controlled study followed by an open­ label; sixty-day extension period. The study and was a follow-up clinical trial to a previously conducted open-label pilot study. As in the pilot study, the goals of the trial were to assess the safety and efficacy of Fattache® dietary supplement. The results described herein are consistent with the pilot study. The primary aims were to identify statistically significant differences in body weight, fecal fat content, blood pressure and serum lipid concentrations by comparing a Fattache® group to a placebo group. Our secondary aims were to define the long-term (90 days) safety profile and efficacy of Fattache® on weight loss, blood pressure and lipid profiles.

Randomization and Blinding Procedure
Patients were randomized to a treatment arm, either placebo or Fattache ®, based on a randomization code. A table of random numbers was utilized to assign patient numbers to either treatment group A or treatment group B. Fattache® and placebo capsules were packaged identically and sent directly to the study center. Only one designated employee at the study center was aware of the contents of the containers and labeled the bottles containing the placebo with a group “A” and the bottles containing the Fattache® with group “B”. The identity of group A and group B (the “blind”) was maintained in the designee’s possession at all times and was not revealed until all 37 patients had completed 30 days of treatment. The results were then compiled with the randomization stratification and sent directly to an off-site, independent consultant statistician for the statistical analysis.

Conclusions

Fattache® had its largest and most consistent effects in lowering body weight and decreasing low-density lipoproteins (LDL’s). For the Fattache® group, the average body weight decreased by -3.63 pounds after 30 days and by -5.65 pounds after 60 days. This weight loss was maintained until the end of the study. The group that received placebo for the first 30 days, group A gained 2.31 pounds. However, after crossing over and receiving Fattache®, the patients lost -2.06 pounds for a negligible net gain.

A plausible reason why patients in the “placebo” group did not experience a net weight loss after crossing-over to receive Fattache® is one of motivation. Once patients did not benefit from an initial weight loss, they were less likely to comply with the study and much more likely to dropout of the study (see table 3).

For LDL’s, Fattache® consistently lowered LDL levels during the 90-day study. Change from baseline for group B was -11.72mg/dl (at 30 days), -l4.92mg/dl (at 60 days), and -15.30mg/dl (at 90 days). Although the magnitude of the difference between the two groups at 90 days was large, the difference was not statistically significant after the first 30 days. This further demonstrates the effectiveness of Fattache® in lowering LDL’s as all patients received Fattache® after the first thirty days.

For HDL’s, Fattache® significantly increased levels at 30 days when compared to the placebo group (-4.61mg/dl for placebo compared to 4.95mg/dl for Fattache®). The Fattache® effect at 60 and 90 days was inconsistent. There was a net decrease at 60 days (from 4.95 to 2.62) and then a trend upward to almost the 30-day level at 90 days (from 2.62mg/dl to 4.45mg/dl). For group A, the HDL level went from a net decrease of -4 .61mg/dl at 30 days to a net increase of 6.13mg/dl at 90 days (after 60 days of Fattache®). By the end of the 90 days, Fattache ‘® increased HDL’s significantly in both treatment groups.

Fattache® clearly lowered total cholesterol after 30 days for group B
(-11.05mg/dl). Group A patients had an increase in total cholesterol by 20.17mg/dl after 30 days. But over time, the Fattache ‘® group (group B) had a small additional decrease at 60 days (to -12.33) and then the change from baseline became even smaller at 90 days (-4.64mg/dl).

The lack of steady cholesterol lowering seen in this study may be due to decreased compliance over time. After 90 days, total cholesterol decreased more for group A than for group B (-14.88mg/dl for group A and -4.64mg/dl for group B). The total cholesterol lowering effects of Fattache® were replicated in both groups as well as the pilot study. Thus, for cholesterol lowering effects alone, Fattache ‘®is an attractive compound.

For blood pressure values, both the placebo group and the Fattache® group had small changes from baseline for the 30, 60 and 90 day measurements. Although there was a statistically significant difference between the two groups for systolic blood pressure at day 30, the magnitude of the difference was small. There were no important changes in blood pressure for either group in any of the measurements over time. While the pilot study suggested a blood pressure lowering trend, this was not replicated in this long-term 90 day study.

Summary

Americans spend more than 30 billion dollars every year on weight loss foods, clinics, books, pills, surgeries, exercise plans, diet sodas, and gimmicks. In spite of these efforts, obesity has never been more prevalent, now encompassing even our nations youths. Cardiovascular morbidity and mortality secondary to obesity is at an all time high. What we, as a nation have been doing thus far to control weight and associated adverse sequelae is clearly not working.

Our society is in great need of clinical research designed to define effective fat loss supplements that may also suppress appetite, inhibit or block lipid digestion and/or increase thermogenesis. To date, natural occurring nutraceutical products containing chitosan, pectin, glucomannan and psyllium seed have gained in scientific interest.

Fattache®, a safe, non-addicting, dietary supplement that combines chitosan, apple pectin, glucomannan and psyllium seed, may offer a unique advantage in the war against weight, fat and cholesterol. Irrespective of diet and exercise, Fattache® has shown compelling improvement in weight loss and lipid profiles over placebo in mild to moderately obese patients. No information is available on the morbidly obese patient population.

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