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Why Fattaché?

The balanced formula of Fattache is a good source of fiber and a natural answer to the overweight problems if combined with  a balanced diet and moderate exercise.

100% natural
Approved by Kuwait Ministry of Health
No preservatives, colors of artificial flavors
No added sugar
Increasing Detoxication
Does not affect the nervous system
Does not contain efedra, efedrina nor its derivations

A high fiber diet protects against obesity & cardiovascular disease therefore our product can help you if you suffer from:

Obesity
Physical inactivity
Dislipidemia (high Cholesterol and triglycerides)
Distribution of the corporal fat
Hypertension
© 2011 All Rights Reserved yourhealthq8.com

Why Fattaché?

The balanced formula of Fattache is a good source of fiber and a natural answer to the overweight problems if combined with  a balanced diet and moderate exercise.

100% natural
Approved by Kuwait Ministry of Health
No preservatives, colors of artificial flavors
No added sugar
Increasing Detoxication
Does not affect the nervous system
Does not contain efedra, efedrina nor its derivations

A high fiber diet protects against obesity & cardiovascular disease therefore our product can help you if you suffer from:

Obesity
Physical inactivity
Dislipidemia (high Cholesterol and triglycerides)
Distribution of the corporal fat
Hypertension

Does Fattaché really work?

Fattaché does work! We are the only product in its class that has clinical evidence published in known medical journals, proving its effectiveness.

Additionally, we have four (4) patents from the government of the United States guaranteeing our customers that our product Does Work! No other brand of weight loss products has as much clinical evidence or patents from the government of the United States as Fattaché.

Does Fattaché upset the nervous system or have any kind of side effect?

No. Fattaché DOES NOT upset your nervous system, and does not interact with any medication. Fattaché is a 100 % natural fiber compound that helps you lose weight while cleaning your system, lowering cholesterol, helping you with triglicerides and controlling high blood pressure.

Anyway, we suggest that if you suffer from any ailment or use prescription medicines, you should always ask your doctor about using these or other products.

What is the recommended use of Fattaché Forte?

You should ingest or take 2 to 4 capsules before each meal (preferably 30 minutes before), with an 8-oz. glass of water starting at breakfast.

Start with 2 capsules and in one to two days maximum, you should notice a change in the frequency of bowel movements. Consuming a fiber supplement will help regulate and normalize your system. If you do not notice a difference, increase the dose to no more than 4 capsules before each meal. If you take them as recommended, you will notice a feeling of satiety before eating and your tendency will be to eat less at each meal.

Remember that when you consume a fiber supplement, it is essential to drink water throughout the day (a minimum of 8, 8 oz. glasses daily is recommended), since this is what will help the movement of the fiber in the bowel. At the same it will clean your system of impurities and will hydrate it

If I forget to take my Fattaché before the meal, What do I do?

Take them as soon as you can even if a half-hour or an hour has passed since the meal. As mentioned before, the ideal time is before the meal so the fibers can trap the greatest amount of fat and get rid of it, in addition to the feeling of satiety. But if you do not do it and consume it later, you will at least be ingesting the fiber supplement necessary for the intestinal system to continue regulating and consequently you will continue losing weight.

So, even if you forget to take them or if you do not have them with you, in any case, take them as soon as you can after the meal

How does Fattaché Forte work?

Fattaché is a 100 % natural fiber supplement, exclusive and patented formula, which contains a combination of fibers. This combination is capable of trapping between 40% and 60% of the ingested fat in its gelatinous core and preventing its absorption, eliminating it with the fiber. This way, your body starts to absorb the fat accumulated in your system. This combination of fibers also helps regulate your intestinal system and lower cholesterol (proven in published clinical trials).

It is very important to point out that cutting down or eliminating all the fat absorption of the body (like some prescription medicines can do), is not good for the body. Fat absorption by the body is important, since many vitamins and minerals are fat-soluble. If our body does not absorb fat, it can not absorb these nutrients either.

What are the ingredients or the composition of Fattaché Forte?

Psyllium, Chitosan, Karaya Gum, Apple Pectin and vitamin C.

What other benefits can Fattaché Forte offer me?

Remember that Fattaché is a 100% natural fiber supplement. The fibers can reduce the risk of heart disease by reducing the total cholesterol and the LDL, reduce the risk of colo-renal and pancreatic cancer, reduce blood pressure, reduce blood sugar and insulin levels.

The fiber also helps to prevent and treat hemorrhoids, diverticulum, hiatal hernias, gallstones, ulcers, and Crohn's disease, in addition to relieving constipation.

How It works?

DIETETIC FIBERS OF CHITOSAN

Are considered dietary fibre polysaccharides those that are not digested by the human gastrointestinal enzymes, are not absorbed and therefore do not produce energy. The fibers act changing physical characteristics of intestinal contents and modifying the absorption of certain substances such as bile salts, cholesterol, fat and so on.

Currently developing the technology applied to foods has reached a high level of refinement and processing, to such an extent that in almost all cases food lost 99% of its fibre content.

In the early seventies emerged a strong interest in the chitosan - a dietary fiber which is found mainly in the animal kingdom - by the need to use the shells or shells of shellfish waste.

Since then numerous research studies have been conducted to find medical applications and biomedical of chitosan.

Some of the properties currently known chitosan are as follows:

It absorbs and traps fat in the digestive tract
It helps reduce body weight
It reduces the levels of total cholesterol
Disminiuye cholesterol linked to lopoproteinas low density (LDL)
Increases cholesterol linked to the high density lipoprotein (HDL), ie the" good "cholesterol
It stimulates wound healing
Act as antacid
It helps prevent constipation

Shares of Chitosan

Chitosan is obtained from the partial acetylation of chitin, which is found naturally in the shell or shells of crustaceans such as crabs, shrimp and lobster, also in the exoskeleton of zooplankton, including choral and aguamala.

Chitosan is not hydrolysable by digestive enzymes in humans, for that reason can be classified as one of the dietary fiber animal. His molecule is similar to the cellulose. However, the chitosan is a cationic polymer which has an amino group at its estructrua chemical, or a polysaccharide nitrogen, which is a feature very different with respect to other dietary fibers. Many features of known chitosan are attributable to its amino group. Among the most notable highlights its hypocholesterolemic action.

The attributes of chitosan is well demonstrated their property antihiperlipedémicas, antihipercolesterolémicas, controlling body weight and stimulate healing.

It has been reported that chitosan is higher than the pectin as an agent hipolipidémico. Under physiological conditions, the chitosan can freeze at least 4 to 6 times its weight in fat. Results suggest that chitosan has a role to interfere with digestion and absorption of fats in the intestinal tract and facilitate the excretion of fat in the stool. These actions indicate that an adequate intake of chitosan may be useful to control and prevent diseases in overweight adults.

A recent research study showed that when administering 3g/día of chitosan in the diet of people is significantly reduced blood levels of total cholesterol and significantly increases the level of serum cholesterol but also combines with bile acids in the tract digestive, and the mixture is formed that is excreted in feces. This results in a reduction in the reabsorption of bile acids, which implies a reduction of the power and consequently low cholesterol levels in blood.

Unlike most of the fibers, the chitosan has a strong positive charge, which allows you to join surfaces with negative charges as fatty acids and cholesterol.

Adding ascorbic acid produces the chitosan still greater excretion of fat through faeces. The increase caused by the effect of ascorbic acid can be explained by a decrease in the viscosity of chitosan, causing an increase in the accompaniment of chitosan and fats. The chitosan does not affect the protein digestibility, this effect is specific lipids.

Chitosan also increases the process of healing wounds. In research studies has been observed that the reepitalización wound in the group which administered the chitosan is higher than in the control group.

This product is not a medicine.

How It works?

Ingredients Amount/capsule Daily Value%
Vitamin C (as ascorbic acid) 10 mg 17%
Chitosan 200 mg
Psyllium Seed (husks) 250 mg  
Karaya Gum (sap) 25 mg  
Apple Pectin (fruit) 10 mg  

* Daily Value not established

Other Ingredients

Gelatin, dicalcium, phosphate, stearic acid, titanium dioxide

RECOMMENDED ADULT USE

As a dietary supplement, take 2 to 4 capsules with 8 oz. of water before meals. Persons with known allergies to any of the ingredients should consult a physician before use. Not recommended for pregnant or lactating women.

* Weight loss should be given along with diet and exercise program.

CLINICALLY PROVEN

No sugar

No preservatives

No Artificial flavors

Nutritional Information:

Each 500 mg capsule

Energy 2.4 kcal 10 kJ
Protein 0.1 g  
Fat 0.005 g  
Carbohydrates 0.485 g  
Fiber 0.485 g  
Sodium < 1 mg  

Effect Fattache

Fattache Forte is a synergistic fiber formulation designed to absorb 4 times (4x) the quantity of fat that any other product can absorb to help you with your weight reduction goals.

Fattache Forte accomplishes this action of increasing the fat binding activity by its synergistic combination with a higher content of chitosan that help in:

Weight Loss

Decreasing Cholesterol Blood level

Decrease Triglycerides Blood level

Increasing Gastrointestinal Mobility

Increasing Detoxication

Why Fattaché?

The balanced formula of Fattache is a good source of fiber and a natural answer to the overweight problems if combined with  a balanced diet and moderate exercise.

100% natural

Approved by Kuwait Ministry of Health

No preservatives, colors of artificial flavors

No added sugar

Does not affect the nervous system

Does not contain efedra, efedrina nor its derivations

A high fiber diet protects against obesity & cardiovascular disease therefore our product can help you if you suffer from:

Obesity

Physical inactivity

Dislipidemia (high Cholesterol and triglycerides)

Distribution of the corporal fat

Hypertension

Medical Trials

EFFECT OF DURABLE FIBER DIETARY SUPPLEMENT FOR WOMEN

(Long-Term Effect of a High Fiber Dietary Supplement on Total Body Weight, Fecal Fat, Lipid Profile and Blood Pressure in Female Human Subjects)

By: Lori Nesbitt, PHD, Carlos M. Ricart, MS, PHD, Jorge Miranda-Massari, PharmD and Michael J. González, DSC, PHD, FACN

(Bio MedicineThe journal of the Hispanoamerican Biomedical Association Vol. 2 No. 8 October, pages S9-s12)

Summary

A mixed-fiber dietary supplement, Fattaché, containing chitosan, pectin, psyllium and glucomannan, was studied to determine its efficacy on dietary fat binding and weigh loss in a double-blind, placebo-controlled trial. Fecal fat content, body weight, blood pressure and lipid profiles were evaluated before and after 30 days of treatment with the mixed fiber supplement. Following the double-blind period, all patients received active treatment, in an open-fashion, for 60 additional days. The patient population consisted of 37 mildly-to-moderately obese, otherwise healthy, volunteers. After only 4 weeks of treatment, the mixed fiber supplement had a statistically significant (p <0.0001, or = 0.005) positive weight reducing effect (-3.63 vs. + 2.34). This weight reduction was associated with a corresponding statistically significant (p <0.0002, or = 0.005) increase in fecal fat content in the treatment groups (+2.48%) vs. the placebo (-3.73%). the placebo (-3.73%). In addition, decreases in total cholesterol, LDL cholesterol and increases in HDL-cholesterol were obtained. These positive results lead us to conclude that Fattaché is a safe and effective mixed fiber supplement for binding dietary fat and weight loss. The lipid profile finding suggests benefits of Fattaché as a natural occurring lipid-lowering agent irrespective of its weight loss potential.

Obesity is a major public health concern because it increases morbidity, mortality, psychological problems, discrimination and reduces economic achievement. It is variable and etiology is of a very complex metabolic and physiologic nature. Obesity can be defined as an excess of adipose tissue or the excessive accumulation of body fat. This excessive accumulation of fat is the primary culprit of obesity's harmful effects. Americans and Puerto Ricans consume about two times as much fat as is considered appropriate (40% vs.. 20%), in addition to consuming the wrong types of fat (saturated, trans-fatty acid and excessive omega 6 fatty acids). The increasing obesity problem in combination with smoking habits, and minimal or absent physical activity accompanied by a high fat intake, are a truly deadly combination that has been linked to cardiovascular morbidity and mortality, and to certain types of cancer (breast, colon, prostate ).

There is a great need for physiological research to help define and describe effective adipose tissue loss that may suppress, appetite, inhibit or block lipid absorption, and / or increase thermogenesis. Of great interest is the use of supplements and nutriceutical products to help create a proper environment or provide a metabolic fine tuning that will facilitate weight / fat reduction goals. For this purpose supplements containing fibers (chitin, chitosan, pectin, glucomannan and psyllium) have been used.

Recently, the use of a modified diet and adjunctive drug therapy have been used to achieve desirable reductions in body weight and lipid levels. To date, prescription drug therapy has been restricted to severe hypercholesterolemia due to safety concerns, inherent to long-term drug therapy. Thus, weight and lipid profile positive results derived from the combination of aerobic exercise, low fat diet, and supplementation has gained scientific and public interest. Supplementation with naturally-ocurring fibers such as chitosan, psyllium, pectin, glucomannan and guar gum are readily available and commonly recommended by physicians and nutritionist to treat mild to moderate hypercholesterolemia.

Chitin is a fibrous material found in the exoskeleton of crustaceans. Chemically, chitin is a polymer primarily formed by repeating units of N-acetylglucosamine with a structure similar to to cellulose. Chitin when heated is converted to chitosan, a polysaccharide, formed mainly of repeating units of D-glucosamine, which have a positive charge. At acidic pH, the amino acid groups take on hydrogen ions resulting in an overall positive charge to the polymer. Due to this positive charge, negatively charged molecules can be attached to these sites and be ionically bound to chitosan. Examples of negatively charge molecules include free fatty acids and bile acids, among other. Chitosan when bound to negative-charge molecules can be excreted out of the body in the feces.

Various animal studies demonstrated an increased lipid excretion and reduced fat digestibility when given chitosan. Nevertheless, despite these interesting results in animal studies, human studies are scarce. To our knowledge, only one study with human subjects using chitosan has been reported in the scientific literature. This was a short-term pilot study designed to monitor safety and to measure fecal fat content and body weight before and after a mixed fiber supplement (Fattache) was given to normal healthy volunteers. Also, fasting blood pressure and lipid profiles were measured as secondary endpoints. The trends resulting from this short-term study with Fattaché were very encouraging. An increased fecal fat, lower body weight, lower LDL, higher HDL, lower triglycerides and lower systolic blood pressure resulted.

This long-term study was designed to measure the effect of a mixed-fiber dietary supplement (Fattaché) on body weight, fecal fat, blood pressure and lipid profile over a longer period of time. In addition, we wanted to determine long-term safety and efficacy.

Methods

This double blind, placebo-controlled study was conducted in 37 female subjects who were mildly-to-moderately overweight (5% to 15% above average body weight) but otherwise healthy. Eighteen patients received placebo and 19 patients received treatment with 500-mg capsules of a mixed fiber supplement (Fattaché) for an initial 30-day period. Fattaché is a mixed-fiber psyllium supplement containing 51%, 40% chitosan, 4% and 4% glucomannan pectin. Following the initial double-blind period, all patients received treatment with Fattaché for an additional 60 days in an open-label fashion.

All eligible patients meeting inclusion criteria were consented and then randomized to treatment or placebo groups. Baseline measurements of fecal fat, body weight, blood pressure and serum lipids were obtained. As a safety measure, a complete blood count, urinalysis were performed to check for long-term safety and efficacy.

All subjects were dispensed Fattaché or placebo (first 30 days only) at regular intervals and instructed to take four capsules twice daily. The participants were also asked to drink 8 to 10 8-oz. glasses of water daily and to continue their normal dietary habits (with no calorie reduction or any type of weight-reduction scheme). Daily dietary food charts were completed by each patient. Compliance with all study-related procedures was strictly monitored.

In order to be enrolled in the study, the patients had to be female, 18 to 70 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 chronic disabling disease or condition or had an allergy to shellfish or pectin-containing products.

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

Baseline (Study day 1): Prior to initiation of Fattaché supplementation, a full fasting lipid profile and a 72-hour stool sample for a quantitative measure of 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 Fattache AM with the meal and 4 pm capsules with the meal. Each dose was to be taken with an 8-oz. glass of water. Patients were also urged to drink 8 to 10-8oz. glasses of water and complete daily food charts.  Concomitant medications and adverse events were recorded.

Study Days 7 and 14: Patients were asked to return to the clinic for routine vital signs, to check for compliance and food chart completion, and was again Fattache dispensed. All non-compliant patients were withdrawn from the study at this time. Compliance was checked by counting remaining capsules of Fattache and by completion of food charts.

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

Study Days 60 and 90: Patients returned to the clinic for open-label visits. A physical exam was completed by a physician. A fasting lipid profile and safety labs were obtained. Routine vital signs, including body weight, were measured and recorded. Patients returned all completed and unused food charts Fattaché capsules.

This study was designed to have 20 patients per treatment group completed a 30-day double-blind period followed by an additional 60 days of open-label treatment of the study and again on days 30 (double-blind period), 60, and 90 (open-label period). The variables were: body weight, percent fecal fat, HDL (high-density lipoprotein), LDL (low-density lipoprotein), total cholesterol and blood pressure (systolic and diastolic)

Double-Blind Period: For each of the seven variables, one sample t-test was used to check for statistical significance from baseline within the placebo group and Fattaché within the group. A two-sample t test was used to check for statistical significance between the placebo and Fattaché groups. The t-test assumes normal distribution of data. In order to verify each variable normal distribution was assessed by a normal QQ plot and a Kolmogorov-Smirnov Goodness of Fit test, and a normal distribution was obtained for each of them.

Sixty and 90-day data were collected for each variable except percent fecal fat, and change from baseline was analyzed (Day 60 - baseline). The statistical analyses used in the double-blind period were also utilized in the open-label part: however, only half the group (control) received placebo for the first 30 days, and patients were randomized using a randomization code. Fattaché and placebo capsules were packaged identically. Then patients were crossed-over to supplementation with Fattaché. Thus, by day 90 this group had received 30 days of placebo and 60 days of Fattaché; Fattaché the group received all 90 days of active treatment. In addition, a within-subject Anova (repeated measures) was done with Greenhouse-Geisser (CG) and Huynh-Feldt (HF) adjustments.

Results

Body weight was measured twice during the double-blind period, once at the beginning of the study (baseline) and a second time at 4 weeks (30 days) of treatment with Fattaché or placebo. The average weight loss for the Fattaché group was 3.63 lbs., While placebo group gained and average of 2.34 lbs. A statistically significant difference between the Fattaché and placebo group was obtained (p<0.0001).

For the open-label study, body weight was measured at baseline (at the end of the double-blind period, on day 60, and on day 90). Patients in the placebo group experienced an average initial weight gain of 2.34 lbs. After being switched over to Fattaché, these patients lost an average of 2.14 lbs. after 30 days of Fattaché suplementation (60 days total in the study). After 60 days of Fattaché (90 total days in study), the ex-placebo group lost an average of 2.06 lbs. The average weight loss for the pilot (Fattaché supplemental group) was of 3.63 lbs. after 30 days, 5.65 lb. after 30 days, 5.65 lbs. after 60 days, and 5.42 lb. after 60 days, and 5.42 lbs. after 90 days. after 90 days. A statistically significant difference was confirmed between the initial pilot and initial control group (p <0.01 at 60 days, and p <0,033 at 90 days).

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 Fattaché or placebo. The amount of fat in each 72-hour stool sample was determined and fat percent was calculated. The supplemental group experienced an average 2.48% increase in fecal fat content, while the placebo group had an average decrease of 3.73% in fecal fat. Fattaché percent fecal fat significantly increased when compared to placebo (p> 0.0002). There was no open-label period for fecal fat content.

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 fiber supplement or placebo. The Fattaché group experienced an average decrease of 11.05 mg / dL in total cholesterol while the placebo group had an average increase of 20.17 mg / dl. Fattaché very significantly decreased total cholesterol compared to placebo in this study (p<0.0001).

For the open-label part, total cholesterol was measured at baseline, at the end of the double-blind period, on day 60, and on day 90. Patients who where given placebo for the first 30 days experienced an average increase of 20.17 mg / dl. After being crossed-over to Fattaché, those patients had a decrease of 21.42 mg / dl after 30 days supplementation (60 days total in the study). After 60 days of Fattaché (90 days total in the study), these patients had a decrease in total cholesterol of 35.03 mg / dl. The average change in total cholesterol from baseline for the group supplemented with Fattaché for the total study was a decrease of 11.05 mg / dl after 30 days, a decrease of 12.33 mg / dl after 60 days, and a decrease of 4.64 mg / dl after 90 Days. A statistically significant difference between the two groups was detected at 30 days (p <0.0001). No statistical difference was obtained thereafter.

LDLs 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 either placebo or Fattaché. The LDLs in the Fttaché supplemented group decreased by an average of 11.72 mg / dl. The LDLs of the placebo group increased by an average of 14.21 mg / dl. In this study, Fattaché significantly decreased low-ensity lipoproteins compared to placebo (p<0.0001).

For the open-label part, LDLs were measured at baseline, at the end of the double-blind period, on day 60, and on day 90. Patients who were treated with placebo for the first 30 days experienced an average increase in LDLs of 14.21 mg / dl. After being crossed-over to Fattaché, these patients had a decrease of 2.77 mg / dl (60 days total in the study). After 60 days of supplementation (90 days total in the study), these patients had a decrease in LDL of 9.01 mg / dl. The average change in LDLs from baseline of the group supplemented in both double-blind and open period was a decrease of 11.72 mg / dl after 30 days, a decrease of 14.92 after 60 days, and a decrease of 15.30 after 90 days. A statistically significant difference was obtained between the experimental and control groups for day 30 (p <0.0001) and on day 60 (p <0.0003).

HDLs 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 Fattaché or placebo. The HDLs in the Fattaché group increased by an average of 4.95 mg / dl while the HDLs in the placebo group decreased by an average of 4.61 mg / dl. In this study, Fattaché significantly increased high-density lipoproteins compared to placebo (p <0.0001).

For the open-label study, high-density lipoproteins (HDLs) were measured at baseline at the end of the double-blind on day 60 and on day 90. Patients who were treated with placebo for the first 30 days experince in HDLs an average decrease of 4.61 mg / dl. After being crossed-over to Fattaché, these patients had an increase of 5.44 mg / dl following 30 days of Fattaché (60 days total in the study). After 60 days of Fattaché (90 days total in the study), these patients had an increase in HDLs from baseline for the group supplemented with mixed fibers throughout the study was an increase of 4.95 mg / dl after 30 days, an increase of 2.62 mg / dl after 60 days, and an increase of 4.40 mg / dl after 90 days. A statistically difference was obtained between the two groups (Experimental vs placebo) after 30 days (p <0.0001), but no statistical difference was obtained for 60 days and 90.

Systolic blood pressure 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 Fattaché or placebo. The Fattaché - supplemented group experienced an average decrease of 2.71 mm Hg after 30 days, while the placebo-treated group experienced an average decrease in systolic blood pressure of 1.94 mm Hg. Nevertheless, a significant difference was detected (p <0.01).

In the open-label part, systolic blood pressure were measured at baseline, at the end of the double-blind periods, on day 60, and on day 90. Patients who were given placebo for the first 30 days experienced an average minimal decrease in systolic blood pressure of 1.94 mm Hg. After being crossed-over to Fattaché, these patients had a negligible increase in systolic blood pressure after 30 days of Fattaché (60 days total in the study). After 60 days of supplement (90 days total in the study), they had a decrease in systolic blood pressure of 2.35 mm Hg. The average change in systolic blood pressure from baseline in the continually-supplemented group was a decrease of 2.71 mm Hg after 30 days, a decrease of 2.27 mm Hg after 60 days., And a decrease of 6.78 mm Hg after 90 days. A statistically significant difference was detected between the supplemented and placebo group at day 30 only (p <0.01).

Diastolic blood pressure 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 Fattaché or placebo. The Fattaché supplemented group experienced an average decrease in diastolic blood pressure of 5.35 mm Hg after 30 days while the placebo group experienced an average decrease in diastolic blood pressure of 6.65 mm Hg. A statistical difference was not detected.

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 who were treated with placebo for the first 30 days experienced an average decrease in diastolic blood pressure of 6.65 mm Hg. After being crossed-over to Fattaché, these patients had a decrease in diastolic blood pressure of 3.56 mm Hg after 30 days of Fattaché (60 days total in the study). After 60 days of supplementation (90 days total in the study) they had a slight average increase in diastolic blood pressure of 4.51 mm Hg. The average change in diastolic blood pressure from baseline in the group supplemented throughout the entire study was a decrease of 5.35 mm Hg. after 30 days, a decrease of 4-45 mm Hg after 90 days. No statistical difference was detected between the supplemented and placebo group.

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, diarrhea, bloating and gas while supplemented with Fattaché. This was described as mild and was determined to be possibly due to Fattaché. Both symptoms were completely resolved when Fattaché was discontinued. A rash was noticed on the second patient. However, this patient was on placebo when the rash developed: thus, this adverse event was not related to Fattaché. It is likely that this fiver supplement will decrease the absorption of vitamins and minerals in order to avoid this inconvenience when using this supplement long-term; vitamin and mineral supplements should be taken 2-3 hours prior to Fattaché supplementation. In Genral, this mixed fiber supplement an considerd be safe if taken in the doses used in this study.

Twenty-two out of 37 patients took at least 90% of the study supplement, 31 of 37 patients took at least 80%, 35 of 37 took at least 70%, while 2 patients had compliance of 53% and 68%. Percent compliance was verified by counting pills remaining in the returned containers.

As in the pilot study, the main reason why the study supplement was not taken was missed meals; patients elected not to take the supplement when a rare morning or evening meal was skipped. The patient that was only 53% compliant, was randomized to the Fattaché group, gained 1.5 lbs. after 30 days, the dropped out of the study. after 30 days, the dropped out of the study. However, the patient that was only 68% compliant lost 6 lbs. after 90 days of treatment with Fattaché. Lastly, only 21 out of 37 patients completed the entire 90 days of treatment.

Discussion

This clinical investigation of a mixed fiber supplement (Fattaché) was undertaken because to date data available on safety and effectiveness of a mixed fiber supplement on human weight reduction and lipid profile are lacking. Animal data exists suggesting an important role for fibers such as chitosan, psyllium, pecting and glucommanan in the treatment of obesity.

The investigation was a double-blind, placebo-controlled study followed by an open-label, sixty-day extension period. This study was follow-up clinical trail to a previously conducted open-label pilot study by our group. The primary aims were to idenfify differences in total body weight, fecal fat content, blood pressure, and serum lipid concentrations by comparing the mixed fiber supplement to a placebo group. Our secondary aims were to define the longer-term (60-90 days) safety profile and efficacy of this mixed fiber supplement on weight loss, blood pressure and lipid profile.

Fattaché also clearly lowered total cholesterol after 30 days (11.05 mg / dl), but over time this change from baseline became smaller (4.64 mg / dl at day 90). The total cholesterol-lowering effects of Fattaché were replicated in both groups as well as in the pilot study. Thus, for cholesterol-lowering effects alone this mixed-fiber supplement might be an attractive alternative therapy.

Fattaché consistently lowered LDL levels during the 90-day study. The effectiveness of Fattaché in lowering LDLs was achieved after the first 30 days on the supplement. For HDLs, Fattaché significantly increased levels at day 30 when compared to the placebo group (4.61 mg / dl for vs. placebo. 4.95 mg / dl for Fattaché). Of interests Fattaché is that HDLs increased significantly in both treatment groups, the ones receiving Fattaché throughout the entire study and the ones that crossed-over after 30 days on placebo.

For blood pressure values, both Fattaché and placebo groups had small changes from baseline for the 30-60 and 90-day measurements. Although there was a statistically significant difference between the placebo and experimented groups at day 30, this difference was small in biological terms. There were no highly relevant changes in blood pressure for either group in any measurements. While the pilot study suggested a blood pressure-lowering trend, this trend did not hold in this long-term study.

Patients found the mixed dietary fiber supplement (Fattaché) easy to take and experienced practically no adverse side effects such as insomnia, headaches and irritability often found in dietary supplements and other aids.

This mixed fiber supplement containing chitosan, pectin, glucomannan and psyllium (Fattaché seems to be a safe, non-addicting and effective dietary supplement for weight, fat and cholesterol reduction. Interestingly, these effects have been irrespective of diet and exercise in middly-to - moderately obese patients. A large double blind 90-day outpatient study in a morbidly obese patient population seems a logical follow-up to these exciting results.

References

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2. Robinson JI. Hoerr SL., J. Strandmark Mavis B. Obesity, weight loss and health. J. AM dietetics Assoc 93:445-449, 1993

3. Petersmark T. Rodriguez JR. Matos MI, MJ Gonzalez. Regional differences in fat cell lipolytic mechanism: A critical review, PR Health Sci J 14:11 - 16, 1995

4. Nauss JL. Thompson JL. Nag J. Vary The binding of micellar lipids to chitosan Lipids 18:714-719, 1983

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10. Ikeda I. Tomari Y. Sugano M. Interrelated effects of dietary fiber and fat on lymphatic cholesterol and triglyceride absorption in rats J Nutr 119:1383-1387, 1989

11. Radzan A. etterson D. Effect of chitin and chitosan on nutrient digestibility and plasma lipid concentrations in broiler chickens.Br.J Nutr 72:277-288,1994

12. Gray DS. Diagnosis and prevalence of obesity. Med Clin North Am 73:1-14, 1989

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