The Effects of a New Food Technology on Body Composition, Body Systems and Blood Chemistries

 Dennis Harper, DO
Thomas McNeilis, DO
Cynthia Watson, MD
Bryan Turner, DVM, MD

(Study sponsored by Isagenix International, Inc.)

Abstract:

Obesity and its associated degenerative diseases including heart disease continue to rise in an unrelenting epidemic. Despite media attention to the magnitude of the problem, people continue in lifestyles that promote disease. However, a growing number in the population recognize the need for personal responsibility in health matters. A new food technology bringing a fresh approach to the problem has helped numerous individuals recapture many aspects of health including substantial weight loss. This cleansing system has captured the attention of the medical community as well because the results are gained without added stimulants, herbs or drugs. An evaluation of the effects of the nutritional cleansing* was performed to systematically examine body composition as measured by deltoid skin-fold or impedance analysis. Moreover, analysis of serum chemistries, lipids, and a comprehensive review of body systems were performed to identify subjective as well as objective findings associated with this technology.

 Null Hypothesis: Consumption of the food technology would have no significant effects on body composition, body systems review or blood chemistry.

Study Design: One hundred volunteers were recruited from four medical practices in Utah and California. Initial body composition was obtained by either deltoid skin-fold measurements taken 8 centimeters below the acromio-clavicular joint or by impedance using a Tanita body composition analyzer Model TBF-105. The volunteers completed a comprehensive review of systems and blood was obtained for a basic metabolic profile, lipid profile and in a small subset for testosterone or oxytocin. Urine was collected for 5- HIAA measurements and a screening urinalysis. Ketostrips were given to the participants to monitor their daily ketone levels during the cleansing cycle. The volunteers were instructed on the recommended cleansing program which requires nine days to complete. At the end of the cycle, the measurements and blood work were again collected. The participants were also asked to measure the circumference of multiple sites and track how many inches were lost over the cleansing period.

Results: Body composition: The average weight loss was 7.6 pounds. For women the average weight loss was 7.2 pounds. For men it was 8.3 pounds. For women the body mass index decrease was 2.4 and for men 2.3. The skin-fold analysis involved 25 patients and these had measurements of circumferences of 13 areas in addition to the skin-fold measurement. Two dropped out and one completed 8 days. Their ages ranged from 20 to 68. Their average weight was 235 pounds. The average total inches lost in the nine days was 16.6 inches. In a previous unpublished trial involving18 women from the ages of 18 to 45 and whose average weight was over 200 pounds, the total inches lost in nine days was 17 inches.

Basic Metabolic Profile: Serum was analyzed for sodium, potassium, blood urea nitrogen, creatinine, chloride, carbon dioxide, calcium, and glucose.   These measurements were unchanged with the exception in men; the average serum glucose declined 11 gm/dl. Total cholesterol declined an average of 24 mg/dl in men and 14 mg/dl in women. Triglycerides decreased by 68 mg/dl in men and 25mg/dl in women. Low-density lipoprotein cholesterol dropped an average 13 mg/dl in men and 7 mg/dl in women. HDL cholesterol declined 0.7 mg/dl in women but increased 1.3 mg/dl in men.

Hormones: In men, testosterone increased 76 ng/dl (18%). In women, oxytocin levels were unchanged. An attempt was made to evaluate urinary 5-HIAA levels as a surrogate for serotonin. The results showed levels essentially unchanged. Urinary 5-HIAA proved difficult to correlate with neuro-chemical erotonin. There are numerous confounding dietary modifiers as well. Unfortunately, in a study such as this, it is not possible to obtain cerebral spinal fluid 5-HIAA levels, which would be a more accurate assessment of the serotonin system.

Body Systems Review: As part of the clinical evaluation, a questionnaire consisting of 175 questions divided into groups related to various body systems was asked. Answers were graded as 0, 1, 2 or 3 from no problem to severe problem. Each subset was totaled. Overall the compiled score decreased 11 points demonstrating lessened somatic complaints and a better overall sense of well-being. The most changed review of systems was neurological/psychological. Mood improved the most. The system groups were labeled neurological, gastrointestinal, cardiovascular, musculoskeletal, respiratory, urinary tract, skin, gynecological, and a total rating.

Discussion: This study demonstrates the remarkable safety of the system. The results are significant in that electrolytes remained stable, as did renal function and serum calcium. Lean body mass was generally preserved and patients reported improved overall health in just a few days. Blood sugars were stabilized and lipids levels improved. Body composition was markedly improved with significant decreases in weight and body fat percentages. Total inches lost were also remarkable. We conclude from this that the total inches lost was a measure of the total body fat lost as indicated by the drop in the body mass index. Subjectively, people reported more energy, a more even temperment, less subjective pain, and improvements in several body system groups. This food technology differs from diet programs in many important aspects. Diets for weight loss typically attempt to cause imbalances in carbohydrate, fat and protein rations. Perhaps for this reason alone, diets are not sustainable and dieters nearly always yo-yo their weight over time causing progressive increases in percentage of body fat. This composition change is a result of losing lean muscle mass during the diet phase and adding extra fat as the weight is put back on over time. This study corroborates company testimonials of multiple general health benefits in addition to rapid but safe reductions in adiposity.

 
Notes:
The Isagenix System is a multifaceted program incorporating education, exercise, healthy lifestyle and dietary choices, and the Isagenix nutritional supplement formulations. This abstract, reprinted in its entirety, is intended to provide a balanced view of the available scientific information related to the Isagenix System. This information is intended for general educational purposes and not to sell specific products. This does not constitute labeling, endorsements or advertisements for any particular products and should not be interpreted as recommending how to treat any particular diseases or health-related conditions.