Clinical Trial Results

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Summary of Conclusions

The detailed conclusions from the clinical trial are detailed at the end of this article. The summary of conclusions from the trial are:

greencheckmarkSubjects using Slenderiix lost over twice as much weight per day versus subjects on diet alone.

greencheckmarkApproximately 90% of subjects achieved their weight loss objective during the study compared to none of the control group subjects. This finding suggests that the faster weight loss weight, with less physical discomfort, improves the discipline required to maintain a weight loss program.

greencheckmarkSubjects taking Rejuveniix along with Slenderiix had a significantly higher rate of weight loss per day. Also, these subjects reported no symptoms of detoxification or withdrawal from processed foods.

greencheckmarkSubjects taking Slenderiix reported increased energy and sense of well-being compared to individuals on diet alone

greencheckmarkSubjects taking complimentary ARIIX products  reported the greatest amount of energy and focus, and had the highest rate of weight loss of all groups

greencheckmarkSubjects taking Slenderiix and complimentary ARIIX products showed significant improvements in these measures: HS-CRP, triglycerides, VLDL, cholesterol, total cholesterol, fasting insulin, serum glucose, HDL, HbA1C and vitamin D. These results suggest metabolic recovery and turning toward systemic homeostasis, thereby decreasing the risk factors for the secondary diseases of obesity, heart disease and cancer.

greencheckmarkTriglyceride levels of all subjects taking ARIIX products significantly improved. There average subject experienced a statistically significant decrease of triglyceride levels of (p<.0005).

greencheckmarkAccording to Anti-aging medicine specialists, the single most important factor to increase life expectancy is the ability to increase HDL cholesterol as high above 40 ng/dL as possible. Within the 12 week period the average increase in HDL cholesterol of 15% brought 90% of subjects within optimal range in all ARIIX groups. This was also significant (p<.0005) suggesting a reduction in risk of all cause death from chronic degenerative disease.

greencheckmarkAll subjects on ARIIX products with initially established inflammatory markers for heart disease and excessive systemic inflammation and oxidative stress showed significant improvements including whole body balance back toward optimal health and metabolism.

 

Methodology

Twenty Three individuals were chosen for the initial study; three men and 20 females ranging in age from 21 to 75. Individuals were selected on the basis of commitment to completing the 12 week course. Subjects were selected due in part to a desire for weight loss, with at least 12, to as much as 120 pounds to lose.

The table below provides the initial weight (in pounds) and variation of both genders.

samplesize

 

Subjects were required to maintain compliance for 12 weeks with a specified nutritionally dense diet, appropriate supplementation, adequate fluid intake, simple exercise, and detoxification and stress management techniques including keeping a food journal, exercise, personal contact, accountability and counsel.

Subjects were given a 1,250 calorie, low-glycemic, low starch, functional food meal plan that included a minimum amount of healthy fats from coconut oil, avocados and raw sprouted nuts or their cold pressed oils. Because the FDA’s defined daily minimum caloric threshold for a “Low-fat Diet” is set at 30% or less of daily calories coming from fat, a minimum of 300 calories of the 1250 allowable calories were specified to be selected from healthy fat.

In addition, to rebalance appropriate ratios of omega 3 fats to omega 6/9 fats within the body quickly, Subjects were required to exclude inflammation-causing omega 6 vegetable which can contribute to inflammatory cytokine production within the body, blocking the pathway to healing metabolism and facilitating rebalancing of hormones. Subjects were also required to exclude high allergen foods including soy, dairy products, grains and starchy vegetables. Subjects were instructed to choose at least twice as many non-starchy fresh vegetables as protein portions per meal to provide plenty of fiber rich carbohydrates which are also dense in anti-inflammatory nutrients.

Some Subjects were also required to take 2000 IU of omega-Q with breakfast and dinner every day. Omega-Q was included as part of the baseline nutritional therapy at a dose of 4000 mgs/ day, in effort to produce a favorable effect on fat-burning metabolism and serum inflammatory markers within a 12 week period. Because sudden excessive amounts of omega 3 fats can have a blood thinning action, Subjects were screened for contraindications and there were none.

Subjects who were using anti-coagulant blood thinning medications such as Coumadin/wafarin. Study Subjects were required to consume 2000 IU of Omega-Q both morning and evening every day for the 12 week trial. Subjects were also required to exclude all inflammation-causing omega 6 vegetable oils such as canola, soybean, grape seed, olive oil and any other oil which can contribute to inflammatory cytokine production within the body, which compete with omega 3 for conversion and would block the pathway to healing metabolism, alter cell signaling and optimal neurotransmitter and hormone rebalance, and counteract the full potential of therapeutic efficacy intended by including Omega-Q.

All groups, except the placebo group, were using the Slenderiix and Xceler8 before each meal throughout the 12 week trial. With all groups the following constants remained for the duration of the study period: food selection guidelines and daily calorie max intake, appropriate hydration to include a minimum of 5 (total based on individual weight) refills of the Puritii water bottle daily, with individual increased adjustments for weight-appropriate amounts of water, and a minimum amount of exercise of 20 minutes of walking, 5 times per week.

Subjects were observed and feedback was given, comparing results of individuals with and without the use of Slenderiix and Xceler8; as well as with Slenderiix, Xceler8 and Rejuveniix. Subjects committed to weekly counseling and instruction with Dr. Hurt. Before and after and at four-week intervals, Subjects’ measurements, weight and photos were documented. Before and after, a comprehensive blood work panel was drawn and evaluated. This panel consisted of serum inflammatory indicators of the presence of fat storage metabolism and known markers that are precursors to diabetes, heart disease and chronic inflammatory conditions such as cancer. Weight, measurements, and fat store location were documented, reviewed, and compared.

Subjects were stratified randomly into 4 groups. The Table below outlines the particular products taken by each Group and what products were taken in conjunction with the 1,250 calorie daily consumption.

stratification

 

Subjects receiving Nutrifii Nutritional supplements of Vitamins, Minerals, Restoriix, and Pure Nourish, and/or Rejuveniix were to take them as directed on the product label. Omega-Q was given, as noted above, in a dose that is double the label guidelines. All subjects were required to take 15 drops of Slenderiix, under the tongue 15 minutes before each meal. Additionally subjects took 15 drops of Xceler8 under the tongue 15 minutes before breakfast and lunch.

Subjects not receiving either Slenderiix or Xceler8 were given a placebo.

Subjects were required to consume 200 calories minimum from organic expeller pressed coconut oil in meal preparation, with the option of an additional 50 calories from raw avocado or raw nuts or organic cold pressed oils. Finally, subjects were required to exclude any foods not listed in the above table, and made specific note to avoid coffee, mint or gum products and artificial sweeteners such as sucralose, aspartame, “Splenda” or “Equal”, common to synthetic “diet” or “lite” food replacements. Natural sweeteners, erythritol or Stevia liquid, were allowed.

In addition to the products identified above, all subjects were required to eat 1000 calories worth of the following foods in the following quantities:

  • Up to two cups of raw, whole, fresh fruit
  • Six or more cups of raw, fresh vegetables
  • 10 to 16 ounces of clean (Free Range, Grass Fed) protein

The following table identifies the classifications of foods available for subjects during the program:

diet

 

Beyond the diet, subjects were required to drink a minimum of 50% of their respective body weight of water, in ounces each day. Regardless of weight, 100 ounces was the minimum amount of water for each Subject each day with no maximum limit.

Finally, subjects were required to participate in an exercise program. Subjects who were currently participating in an exercise routine at the onset of the study were allowed to continue with that program, at the review of Dr. Hurt. Subjects who were non-exercisers, were required to walk for at least 20 minutes, a minimum of five days each week.

Results

Of the initial 23 subjects, 19 completed the program. Results of following a regimen of calorie limited nutrient dense diet, appropriate supplementation, hydration, and detoxification with moderate exercise, coupled with use of specific products yielded statistically significant results compared to reducing calories alone.

The table below provides a summary of the average rate of weight loss per day over time.

results

 

Since subjects were classified into four equal groups (n=5), an ANOVA was conducted to determine significance across groups. Even given the small sample size created by the factorial design, results show that significant differences existed between groups (F ratio 9.7 p<.01).

After four weeks, Subjects in the Control Group C were allowed to take Slenderiix. At the crossover, all of the groups using Slenderiix (A, B, D) had lost an average of 14.3 pounds per month. In each group, 24.4% more weight loss was observed, than was experienced in the placebo group within the same time frame. Individuals in the placebo group were eating the same meal plan, water and exercise routines as that of the Slenderiix using groups. In addition, placebo group Subjects were receiving the exact same nutritional supplementation as the Subjects in group A; the only difference in these two groups was between the active Slenderiix for the Group A Subjects, and the inactive Placebo product for the Group C Subjects. Placebo Subjects lost an average of only 11.48 pounds employing the exact same lifestyle efforts and timeframe as all other groups.

Within this initial 4 week timeframe, Placebo Subjects were the only group that reported feeling hungry, fatigue and weakness upon exercise, and difficulty at being around food or in the presence of others at mealtimes. By the third week of the program, Placebo users were beginning to express difficulty at continuing to participate with the trial for the remaining 9 weeks.

Even though the amount of weight lost within all Slenderiix-using Groups, A, B and D reflected less than 1 pound average variance among the three groups, there was a marked difference in the level of enthusiasm, perception of the ease of the program, increased sense of well-being, continual increase in daytime energy and desire to become more active as time went by, within Group D. This group was supported by not only Slenderiix and Xceler8, but all of the Foundational Supplements, as well as Rejuveniix.

Group D experienced the highest rate of weight loss per month at 16.1 pounds per month. Because of the remarkable difference in positive mental attitude coupled with weight loss success, it was decided Groups A, B, and C would, at the crossover time, convert to the Group D regimen for the 8 week duration of the trial.

Even with a relatively small sample, the difference between groups, as well as individual improvement on pre and post testing of both subjects was statistically significant. Two-tailed results suggest a statistical significance in all groups, except the placebo group, when compared to diet alone.

figure2

 

Furthermore, all groups were found to be significantly different from no diet whatsoever (p<.0001).

It is generally maintained that weight loss that is too rapid and sustained over a long period of time is not optimal. Therefore, the rate of weight decline, reflective of stabilizing metabolism, is provided in the table below.

figure3

 

As the table depicts, over time, the rate of weight loss diminished. That notwithstanding, the rate of weight loss in each category, statistically exceeded the rate of weight loss on diet alone. 89.5% of subjects exceeded personal targeted weight loss.

Of the two Subjects who did not reach their 12 week projected weight goal, one Subject was only 1.6 pounds short of the 25 pound projected possible weight loss for females, and the other Subject was within 3.8 pounds of study projections. It should be noted that the latter Subject had exceeded her personal goal of losing 20 pounds. Once personal expectations were fulfilled at completion of the 7th week of the trial, no additional weight was lost in the remaining 5 weeks of the program. This observation supports psychological theory that personal expectations play a significant role in weight loss outcomes in regard to the possibility of subconscious behaviors sabotaging what ultimately may be possible. In total, the rate of weight reduction per day experienced by all Slenderiix using groups consistently exceeded the rate of weight loss compared to calorie restriction diet alone.

Biomarkers which are key indicators of metabolic syndrome, diabetes, cardiac disease and cancer risk factors were measured through serum testing both before and after the 12 week trial. Unfortunately, circumstances limited collection of lab values from every Subject, which prevented reporting on every lab value examined. The individuals were to get a selected list of disease markers drawn, which are known in preventative medicine as indicators of fat storage, obesity, diabetes and precursors to heart disease and some cancers. Because these labs were to be ordered and collected by each subject’s physician, several physicians declined follow-up labs after the trial was over. In many cases, this was due to the obvious considerable weight loss and physicians’ no longer deemed the labs as medically necessary, which precluded insurance covering the cost of the follow up labs. Due to logistical complications such as this, almost half of Subjects were not able to provide follow up lab values for certain tests.

Pre and post measurements taken from subjects who obtained post blood work (n=10) found statistically significant differences in each subject on measures generally associated with improved health, and markers associated with disease. The table below provides the paired-t differences between subjects across all groups (excluding placebo). Given the limited sample size related to factorial design, although statistically significant differences in blood markers were found in ALL groups except the placebo group, the interpretive power of such small samples sizes resulted in the exclusion of such reporting values for this report.

blood-tests-before-after

A collection of serum markers that accompany the onset of abnormal fat storage, specifically in the disproportionate deposition of visceral adipose tissue (VAT), have been associated with the pathology of insulin resistance. These blood levels have interrelated relationships in obesity-related disease pathology. Integrative physicians now understand that although individually these lab indicators may enter the picture at different times due to biochemical individuality, certainly metabolic syndrome is continuing to worsen along with the increased inability to shed excess weight easily, and over time the appearance of more and more of these particular serum markers continue to underscore the depth of the disease pathology that is pushing the patient closer to cardio-metabolic disorders and hormone related cancers, our number one and two causes of death. These serum levels are as follows: elevated triglycerides, total cholesterol serum insulin; decreased HDL cholesterol and glucose tolerance.

Over time, insulin resistance progressively becomes more severe and continues to affect function of more organs. When serum glucose levels remain elevated, there is increased likelihood of protein glycosylation and overproduction of free-radical producing oxidative stress, which have proven association with initial obesity, and eventual atherosclerosis, type II diabetes, heart disease and cancers. The body’s typical reaction of producing more and more insulin leads to insulin resistance in various locations throughout the body as disease progresses. In the skin, insulin resistance can be revealed as acne, while insulin resistance in the brain over time becomes Alzheimer’s—recently given the name Diabetes Type III.

The Serum Measures Chart above reflects that all serum risk factors tested for cardio-metabolic disorders were significantly reduced, and physical measurements of subjects lost a proportionately larger amount of fat in the waist area as compared to the chest and hips, confirming the ability of the program to target release of fat stores preferentially in the area of visceral adipose fat. This indicates a regain in glycemic control, thus reversing the progression of insulin resistance (first heralded by the visible increase in visceral adipose tissue, or belly fat), and the pathological risks that would have followed in time.

Cardio-metabolic Risk Assessors that accompany excess Visceral Adipose Tissue

Typically, as insulin secretion increases, blood triglycerides and glucose levels continue to rise, while HDL levels slowly decrease and VAT begins to accumulate. Since insulin is released in response to too much glucose in the blood, and HbA1c represents the amount of hemoglobin molecules that have had glucose molecules attached to them in the blood stream, these two serum markers typically rise and fall together. Serum levels of insulin within study Subjects decreased an average of 27.7%, and correlating HbA1c also decreased 4.4%.

Even though all cholesterol levels were monitored and improved upon, the cholesterol values that are specific to indicate systemic inflammation are now accepted to be most pertinent to reversing the interrelated risks of heart disease and obesity.

The pathology of arterial plaque formation in heart disease has been proven to be caused by several factors effecting inflammatory response to the small vascular injuries that occur from a cascade of reactive events. Over-production of insulin from sugar and starch consumption, increased platelet adhesion due to omega 3 fat deficiency and omega 6/9 excess, emotional stress and oxidative stress all contribute to inflammatory pathology. If inflammation is eliminated, arteries are clear, regardless of total cholesterol levels. Across all cholesterol markers, subjects responded with significant improvements in all areas.

The fraction of cholesterol that indicates potential endothelial inflammatory damage is called Very Low Density Lipoproteins (VLDL). Due to excessive free radical production, when cholesterol is oxidized into VLDL, it indicates an insufficient amount of antioxidants available within the body. VLDL can be significantly reduced by supplementing adequate vitamins, minerals and antioxidants, and appropriate to the level of stress of the individual. This inflammatory marker, VLDL was significantly reduced.

The National Institutes of Health funded the VITAL study to asses the effect of vitamin D and omega 3 supplementation on the prevention of cancer and heart disease.(23) This was a large-scale randomized trial which also made correlations to fasting insulin, glucose, altered cholesterol ratios and the prevalence of metabolic syndrome. Findings proved that the lower the serum vitamin D, the more prevalent these inflammatory makers for insulin resistance progressing to metabolic syndrome. Increasing serum 25(OHD) is associated with a responsive lowering of VAT, triglycerides, triglyceride/HDL-cholesterol ratio. Within this trial period, Subjects serum vitamin D increased an overage of 15.7% overall, raising serum levels of 9 out of 10 subjects to reflect an optimal range of 40-69 ng/ml, and the remaining subject at 39.10 ng/ml. Due to the seasonality of the trial beginning fall and ending mid-winter, these results are impressive, considering vitamin D levels typically plummet in winter months and fat stores simultaneously increase.

Higher levels of Highly Sensitive C-Reactive protein are linker to higher occurrences of sudden cardiac death, strokes, peripheral artery disease and myocardial infarction. HS-CRP is an inflammatory particle produced by the liver in response to stressors. Trial Subjects averaged a 24% reduction in HS-CRP.

Since about 50% of all heart attacks and strokes effect people with normal total cholesterol levels, anti-aging medicine specialists now look to a combination assessment of the inflammatory HS-CRP along with the ratio of Triglycerides (TG) to High Density Lipoprotein (HDL) cholesterol to offer more effective proactive approaches to risk assessment. (22,25,26) As most triglycerides in the blood are indicative of carbohydrates that have been converted into fat that will be stored specifically in the visceral adipose tissue area, reducing serum levels of triglycerides and comparing these levels to sufficient quantity of HDL is a significant indicator of the degree of disease pathology. (24)

Data from the Third National Health and Nutrition Examination Survey (NHANES III) indicated that the most frequently noted serum markers among overweight and obese adolescents are high TG (25–30% of adolescents) and low HDL cholesterol levels (40–50% of adolescents). (26) The table below reflects the results of TG/HDL Ratio improvements within the 12 week period.

tglhdl-ration

 

The ratio of TG to HDL is a reliable indicator of the extent of insulin resistance on cholesterol metabolism. (27) Subjects within the Slenderiix Clinical Trial produced a 41% reduction in Triglyceride to HDL ratios, significantly reducing serum-defined insulin resistance and cardio-metabolic risk.

Conclusions

Results of the study found that all groups statistically lost more weight loss than no weight loss regiment whatsoever. However, subjects using Slenderiix lost just over twice as much weight per day (.51 lbs p/day) compared to subjects on the strict diet only. Subjects taking Rejuveniix in conjunction with Slenderiix had a significantly higher rate of weight loss per day.

Subjects taking Slenderiix also reported increased energy and sense of well-being compared to individuals on diet alone. Subjects taking a placebo reported significant hunger, low energy and intolerance to exercise, in between meal headaches, and difficulty around others eating food more than all other groups. Subjects who used ARIIX products and Rejuveniix reported the greatest amount of energy and focus, and had the highest rate of weight loss in all groups.

Unlike any other group, no single subject taking Slenderiix and Rejuveniix combined reported mild to moderate headaches, fatigue and symptoms of detoxification or withdrawal from processed foods with in the first week. Further study on these self-reported benefits of Rejuveniix is warranted.

Typical of individuals overweight, most subjects showed elevated levels of HS-CRP, triglycerides, VLDL cholesterol, total cholesterol, fasting insulin, serum glucose, HbA1C, and depressed levels of HDL and vitamin D. Statistically significant improvement occurred for all subjects taking ARIIX Products in addition to diet and exercise only across all measures.

These results suggest metabolic recovery and turning toward systemic homeostasis, thereby decreasing the risk factors for the secondary diseases of obesity, heart disease and cancer.

All subjects on ARIIX products with initially established inflammatory markers for heart disease and excessive systemic inflammation and oxidative stress showed significant improvements including whole body balance back toward optimal health and metabolism. T

Triglyceride levels of all subjects taking ARIIX products significantly improved. There average subject experienced a statistically significant decrease of triglyceride levels of (p<.0005). According to Anti-aging medicine specialists, the single most important factor to increase life expectancy is the ability to increase HDL cholesterol as high above 40 ng/dL as possible. Within the 12 week period the average increase in HDL cholesterol of 15% brought 90% of subjects within optimal range in all ARIIX groups. This was also significant (p<.0005) suggesting a reduction in risk of all cause death from chronic degenerative disease.

Approximately 90% of subjects achieved their weight loss objective during the study compared to none of the control group subjects. This finding suggests that the faster weight loss weight, with less physical discomfort, improves the discipline required to maintain a weight loss program.

Finally, the physical, psychological and emotional changes in the subjects were observed. Subjects losing weight often comment on increased enthusiasm, energy, and confidence. The psychological impact of being empowered with the knowledge and ability for individuals to create a metabolic shift in a completely new direction in such a short period of time was transformational for all test subjects taking ARIIX products, rather than calorie reduction alone.

Additional longitudinal studies would prove beneficial to evaluate subjects’ conformity to the consumption of metabolic supportive supplements, modified diet, and moderate exercise adhered to during the trial.

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