OBJECTIVE: The purpose of this clinical trial was to evaluate the effect of a multifaceted approach to weight loss rather than traditional calorie restricted diets. “Life Coaches” were implemented during this study. Three individuals, a physician, a personal trainer and nutritionist, and a motivational speaker were utilized to provide videos to the participants. These videos contained supplemental information regarding nutrition, exercise and diet counseling.

DESIGN: Analysis of the results of the effect of combining the following seven factors on individual weight loss during a 40 day time period. 

• Ten-day Herbal Cleanse to aid in optimal gastrointestinal function and detoxification.
• Protein Meal Replacement Shake to be used in place of one meal per day for 30 days.
• Non-prescription oral appetite suppressant.
• Daily supplementation of Lights On & Lights Off during the 30 day dietary change period.
• Diet consisting mostly of low glycemic carbohydrates (<65) & unsaturated fats. Also a minimum daily intake of 80 ounces of water.
• “Life Coach” counseling on foods to eat and foods to avoid (not a calorie restricted based plan).
• Low Impact Exercise routines specific to the individuals.

RESULTS: Twenty participants, male and female, ranging in age from 19 to 62 with a BMI of 25-35 were studied. On Day One of the study all participants’ weight and BMI were recorded using a body composition scale.  This reading was repeated on a weekly basis for the duration of the trial. There were two individuals that did not complete the study. One dropped out approximately two weeks into the program, and the other at approximately three weeks in.
We observed a satisfactory weight loss in all trial participants.  Individual losses ranged from 6-23 pounds with an average of 12 pounds per person.  Expected results based on nutritional advice was a minimum of a ten-pound weight loss in 40 days and a minimum drop in body fat percentage of 1-2%.

Participants were given a ten-day aloe and herbal based colon-cleanse product, delivered in 2-ounce individually prepared doses taken at bedtime each night and instructed to reduce their intake of breads, pasta, cheese, dairy and soy products. (See Table 1 for listing of ingredients.)  The aloe/herbal cleanse was tolerated by all trial participants with acceptable results achieved (no diarrhea, cramping, and at least one bowel movement per day). Participants were asked to record if they had a change in bowel pattern with use of the Herbal Cleanse product. No adverse events were reported by trial participants.
 
Following the herbal cleanse, a protein whey-based Meal Replacement Shake to address nutritional deficiencies was started. (See table 2 for meal replacement ingredients.) Participants were instructed to use the shake to replace one meal daily. About half of the participants elected to use this product to replace breakfast, and the others chose to use the shake for lunch. The meal replacement shake was found to be a satisfying substitute for a single meal with satiety lasting between 1-3 hours per shake.
  
A non-stimulant appetite suppressant, containing ingredients based on precursors to certain neurotransmitter production was provided.  (See table 3 for ingredient list.)  Participants were instructed to take this supplement daily at the first symptoms of hunger and could repeat it if necessary. The appetite suppressant supplement was found to be beneficial in controlling their appetite, which resulted in less food consumption, and was also found beneficial in reducing frequency and intensity of food cravings.

A daily supplementation regimen of Lights On & Lights Off was begun during the thirty day meal replacement period. Participants were instructed to use Lights On during the morning hours and Lights Off in the evenings. Lights On (See Table 5 for list of ingredients) provides beneficial supplementation to enhance focus and concentration which helps participants make better eating choices and also provides energy. Lights Off (See table 6 for list of ingredients) is taken an hour prior to bedtime and helps participants to relax and prepare for sleep, as adequate sleep is necessary to detoxify and improve gastrointestinal health and thereby lose weight.
 
Participants simultaneously received counseling and advice from the DynaMAXX “Life Coaches” in regard to nutrition and diet, exercise, lifestyle changes, state of mind, and motivational help.  Participants were encouraged to keep their carbohydrate intake to a designated carbohydrate exchange each day, but the carbohydrates were of their own choosing. Advice was given regarding choices of foods to eat often and foods to avoid based on a low-glycemic index diet, and consumption of primarily unsaturated fats and whole unrefined grains was also encouraged. It was further recommended to participants that they stay below a Glycemic Index of 65. Participants were instructed to not consume diet, sugar free or other carbonated beverages.  Participants were allowed to determine the number of calories consumed in order to allow for optimal compliance and adherence to the trial; however, they were encouraged to adhere to a 1,200-1,500 calorie diet on average over the 40 day time period.

Each participant was then individually interviewed regarding each of the products mentioned above.  They were questioned on changes in bowel elimination, effectiveness of the appetite suppressant in regard to food cravings, and caloric intake during the study.  Participants were also encouraged to keep a journal regarding calorie intake, appetite suppression, and satiety of the shake. Finally, participants were asked to rate the meal replacement shakes in their ability to replace a meal and satisfy their hunger. (See Appendix A for participant’s individual results.)

CONCLUSION: The approach outlined in this trial enabled its participant’s to achieve expected weight loss results. On average, participants lost 12 pounds, 1.6 % body fat and 1.9 points from their BMI. These changes reflect the expected results according to the study guidelines. Since these factors are all associated with co-morbid health conditions, even a small loss stimulates health gains. This loss was accomplished while avoiding the usual pitfalls associated with “dieting and caloric restriction” that often occurs when there is no other functional, metabolic, psychological, or nutritional support addressed.  The addition of supplemental products and access to life coaches had a great impact on the participant’s overall sense of well being; most felt that they were receiving support that had been lacking in previous diet attempts. All participants agreed that the approach outlined in this trial benefited their weight loss goals and all were willing to continue this regimen to reach their individual goals and would recommend without hesitation this approach to others. (See Appendix B for their personal satisfaction ratings.)

Table 1: Aloe Herbal Cleanse Aloe vera whole leaf juice, aloe vera gel juice, hydrolyzed collagen, cha de bugre, milk thistle, dandelion, fennel seed, ginger root, slippery elm, alfalfa, burdock root, black cohosh, senna leaf, cascara sagrada, citric acid, zantham gun, guar gum, stevia ascorbic acid, sodium benzoate and potassium sorbate used to preserve freshness

Table 2:  Whey Protein Meal Replacement Shake Whey protein concentrate, rice bran, crystalline fructose, fibersol 2, maltodextrim, magnesium phosphate, cellulose gum, soy lecithin, dextrose, salt, sodium caseinate, mono and triglycerides, vanilla extract, potassium phosphate, calcium phosphate, stevia ascorbic acid, citric pectin, xanthan gun, potassium citrate, acesulfame potassium, alpha lucophetols, natural and artificial flavor, natural color

Table 3:  Appetite Suppressant Proprietary Blend 450 mg Citrus aurantium, L-tyrosine, slendesta potato extract, phospholean EGCG, yerba mate lead, panax ginseng root, maca root, 5-Hydroxytryptophan, vitamin B6, chromium

Table 4:  Lights On Fibersol-2 (Dietary fiber), Glucosamine hci, Guarana (seed), Taurine, Maca (root), Green Tea, Glucoronolactone, Tyrosine, Pau d'Arco, Siberian Ginseng, Angelica (root), Hawthorn (berry), Resveratol, Gofi berry powder, Acai berry powder, Vinpocetine Periwinkle extract

Table 5:  Lights Off Fibersol-2 (Dietary Fiber), L-arginine, Pomegranate concentrate, Mandarin Orange, Gaba, L-theanine, Lavendar flower extract, Milk Thistle seed extract, Wuling Mushroom extract, Chamomile flower extract, Aloe Vera powder, 5-HTP, Melatonin, Stevia