The Enzyme Diet™ Clinical Study

Infinity2 Research Department

INTRODUCTION:

The incidence of obesity and its serious health consequences including high cholesterol, high blood pressure, sleep apnea, joint problems and increased risk of diabetes, heart disease and some cancers continue to rise. Statistics indicate that two thirds of U.S. adults are overweight, and nearly 23% are considered clinically obese. In response, a variety of weight-loss diets and meal replacement programs have been promoted as a solution to the problem. Unfortunately, many of these diet programs are difficult to follow and most do not provide adequate amounts of the essential vitamins and minerals. In fact, many of the liquid protein diets in the 1970's were so poorly formulated that they resulted in adverse consequences.

Today, there are a number of popular meal replacements on the market that contain adequate nutrition and are generally without risk for the average dieter when used to substitute one or two meals. They range in quality and effectiveness, but all these products still neglect some important principles of nutrition and contain a significant amount of hydrogenated oils, added sugar, artificial flavors and preservatives.

The Enzyme Diet™ is designed to make weight loss simple and provides all the nutrients the body needs to maintain optimal health and support the metabolism. Unlike other meal replacements on the market, The Enzyme Diet™ is low in sugar and does not contain hydrogenated oils or artificial flavors or sweeteners. The Enzyme Diet™ is also unique in its use of a patented, stabilized form of glutamine to support the maintenance of lean muscle mass during weight loss and the use of patented amino acid chelated minerals that are more bioavailable than the mineral salts commonly used in supplements, meal replacements and other products. Additionally, it is the only meal replacement product on the market to utilize enzymes to enhance and ensure the delivery of the key nutrient ingredients. A multi-center, physician supervised, controlled trial was conducted to demonstrate the effectiveness of The Enzyme Diet™ program in a controlled setting.

METHODS:

The multi-center, physician supervised, controlled trial was conducted in three physician offices in Dallas, San Marcos and Tucson. Subjects were required to meet the following guidelines for eligibility as a participant:

• Greater than 20 pounds overweight
• Age = 20 years to 70 years
• Has not used supplements with stimulants (ephedra, caffeine, etc) for past 30 days
• Has not used the Atkins Diet or other high protein diet in last 30 days
• Stable glucose levels
• Stable cholesterol levels
• Stable blood pressure
• Stable thyroid levels
• If female, not pregnant or breast-feeding

Thirty-eight (38) healthy obese and overweight men (n=10) and women (n=28) with a mean Body Mass Index (BMI) of 35 participated. Subjects were assigned to one of three different dietary protocols using The Enzyme Diet™ Superfood as a meal replacement for either two or three meals per day. Group A replaced two meals with The Enzyme Diet™ Superfood and ate a sensible 3rd meal and two snacks consisting of fruits and/or vegetables. Group B replaced three meals and one snack each day with The Enzyme Diet™ Superfood and ate two snacks consisting of fruits and/or vegetables for the first four days of each week, then replaced two meals per day with The Enzyme Diet™ Superfood and ate a sensible meal and two snacks for the remaining days each week. Group C followed a combined program where weeks one and three were the same protocol as group B and weeks 2 and 4 were the same as group A. Subjects were weighed weekly and measurements were taken pre-study and at the end of 4 weeks (28 days).

RESULTS:

All participants lost weight and weight loss ranged from 3 pounds to 17 pounds. Average weight loss for groups A, B and C were 8.67 lbs, 8.95 lbs and 8.2 lbs respectively, and the average weight loss for all subjects in all groups was 8.6 pounds during the 28-day study. There were no significant differences in weight loss between the three groups.

Subjects lost an average of 2.5 inches from the waist, 2.4 inches from the hips and a total of 8.9 inches. There were no changes in blood pressure.

Ten subjects had resting metabolic rate measured weekly during the study. There was a trend toward an increased metabolic rate in most of these subjects, but the changes were not significant.

Overall attrition in the program for all groups was 18% (31 of the 38 subjects completed the study), which is significantly better than most weight loss
programs. Adherence was better (although not significantly) in Group A indicating the standard recommendations of replacing 2 meals per day may be easier to follow than replacing 3 meals.

Two subjects had elevated cholesterol and triglycerides at the beginning of the study. Both subjects experienced significant improvements in blood lipid levels during the study. Subject 1's total cholesterol dropped from 255 mg/dL to 212 mg/dL and triglycerides dropped from 1074 mg/dL to 345 mg/dL. Subject 2's total cholesterol dropped from 284 mg/dL to 213 mg/dL and triglycerides dropped from 196 mg/dL to 160 mg/dL.

DISCUSSION:

Meal replacement programs are not new and were very popular in the 1970's. Unfortunately, many of the liquid protein diets in the 1970's were poorly formulated and resulted in some adverse consequences. However, newer nutritionally-balanced formulas have been introduced to the market that have the combined appeal of convenience with good balanced nutrition. Several studies have shown that when dieters are given meal replacements as part of a reduced calorie food plan, they lose more weight than those prescribed the same number of calories with no meal replacements. A recent review of 29 studies of overweight and obese people who participated in weight loss programs in the U.S. led the authors to conclude that meal replacements make it easier for people to follow a restricted energy (low calorie) regimen (1). The results of this clinical study using The Enzyme Diet™ are consistent with previous studies demonstrating successful weight loss using meal replacement products and greater adherence and better attrition than conventional diets [(only 18% attrition in this study compared to attrition rates of 43%, 60%, and 36% for Low Carbohydrate/High Protein, Zone and conventional diets, respectively (5)].

Other researchers have also reported greater compliance using meal replacement programs. David Herber, M.D., PhD, the Director of the UCLA Center for Human Nutrition clearly made a case for the wise and practical use of meal replacements in a comprehensive lifestyle strategy in his book The Resolution Diet (4). He reported that published studies from the UCLA group with hundreds of participants at six different sites across the U.S. reveal consistent weight loss and excellent compliance with meal replacements (3).

Another study in Germany compared the use of two meal replacements per day with simply trying to count calories in diets of 1200 to 1500 calories per day (2). They found that the group using meal replacements lost an average of over 15 pounds, while those who simply cut back on their intake lost only 3 pounds on average after 12 weeks. The subjects in our study using The Enzyme Diet™ lost an average of 8.6 pounds in 4 weeks, which is significantly greater than either the meal replacement group (average 5 pounds in 4 weeks) or the group consuming

conventional foods (average 1 pound in 4 weeks) in Ditschuneit's study. These weight loss results are also significantly greater than those in another study
conducted by Landers who found that average weight loss in the popular diets such as the Zone and Atkins Diet was only 3.7 pounds for 4 weeks (5).

Although this study using The Enzyme Diet™ was only 28 days and did not look at long-term weight maintenance, published studies with long term follow up of those who have lost weight show that those using meal replacements have greater success at keeping it off. In fact, a one year follow up of weight loss in two comparable groups showed that the group using meal replacements maintained their weight loss, while the group that did not use meal replacements gained back almost all the weight that had been previously lost. A different five year follow up study yielded similar results.

In Dr. Heber's studies (3) both men and women maintained an average weight loss of about 14 pounds after 2 years. In Ditschuneit's study in Germany comparing meal replacements with conventional diets (2), they found that during the two years following the study the meal replacement group lost an average of an additional 6.6 pounds, or an effective total of more than 20 pounds, using just one meal replacement as maintenance. It is expected that The Enzyme Diet™ would yield similar results demonstrating success at maintaining the weight loss. The Enzyme Diet™ guarantees the best of nutrition without the burdensome task of counting daily calories and the inconvenience of structuring each meal on one's menu.

CONCLUSIONS:

The Enzyme Diet™ Superfood weight loss program produces superior weight loss results compared to other weight loss programs. Additionally, the results were achieved with no adverse effects on blood pressure, cholesterol or metabolic rate. Attrition rates for The Enzyme Diet™ program were low (18%) compared with other weight loss programs (36% and or more), indicating that The Enzyme Diet™ weight loss program is both effective and easy to follow. Attrition was substantial for all other plans at 43%, 60%, and 36% for LCHP, Zone and conventional diets, respectively (5). Although this study was only 28 days and involved a relatively small number of subjects, it demonstrates conclusively that The Enzyme Diet™ can be used as a safe, convenient and effective weight loss program. Additional larger, long-term studies are recommended to record the long-term effects of this weight loss program on health and obesity.

Although there are published research studies that demonstrate the effectiveness of meal replacement programs for weight loss, none of these studies have utilized a meal replacement product with the unique nutritional attributes of The Enzyme Diet™

• Low in sugar.
• Free of hydrogenated oils and artificial flavors.
• Patented, stabilized glutamine.
• Whole food nutrition.
• Patented enzyme delivery.

The Enzyme Diet™ is a safe, effective product for promoting health and weight loss.

Reference List
1. Anderson, J. W., E. C. Konz, R. C. Frederich, and C. L. Wood. Long-term weight-loss maintenance: a meta-analysis of US studies. Am.J.Clin.Nutr 74: 579-584, 2001.
2. Ditschuneit, H. H., M. Flechtner-Mors, T. D. Johnson, and G. Adler. Metabolic and weight-loss effects of a long-term dietary intervention in obese patients. Am.J.Clin.Nutr 69: 198-204, 1999.
3. Heber, D., J. M. Ashley, H. J. Wang, and R. M. Elashoff. Clinical evaluation of a minimal intervention meal replacement regimen for weight reduction. J Am Coll.Nutr 13: 608-614, 1994.
4. Herber, D. The Resolution Diet. Avery. 1999.
5. Landers, P., M. M. Wolfe, S. Glore, R. Guild, and L. Phillips. Effect of weight loss plans on body composition and diet duration. J Okla.State Med Assoc. 95: 329-331, 2002.

© 2004 Infinity2, Inc.

Consult your health practitioner on all medications, herbs and supplements you are taking. This information is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of a qualified health professional with any questions you may have regarding a medical condition or symptom. Consult your health professional before beginning The Enzyme Diet™ or any other diet or exercise program. Some herbs can react with medications, both prescribed and over the counter, and some herbal combinations can cause serious side effects.