Slimtrax® vs. formoline L 112 1 Trial summary: Trial and comparison of the efficacy of two commercially available products and nutritional concepts for weight reduction in overweight women and man. Observation period : 2005 Slimtrax® vs. formoline L 112 2 Introduction and trial design In a study conducted in 2005 a total of 32 adult overweight volunteers (16 female, 16 male) where monitored while using two products: The dietary supplement SLIMTRAX® (Pharmessen, San Diego, USA) and the, healthcare product “formoline L 112” (Biomedica Pharma-Produkte, Rodgau), for weight reduction. Selection and allocation of the volunteers The selection and allocation of the volunteers for the trial groups was conducted at random. Because it is proven that men loose weight much 4 to 6 times faster than women, separate female and male trial groups where established. Instruction of the volunteers The volunteers were introduced to the products. They received the information material normally delivered with the products. They did not receive information about other volunteers in order to eliminate contact between them. The volunteers received no information about the progress of weight reduction in other volunteers to avoid a competitive situation. Studies have shown that psychological factors, such as those addressed here, can influence the outcome and success/failure of weight reduction and diets. [1 – 3]. The volunteers where asked to make any changes in daily routine. They received the products for free. Composition and application of Slimtrax® Slimtrax® is filed under the pharmacy code number 3 91 28 07. One Slimtrax® tablet has 55 % microkristalline cellulose, 33 % oligofructose, anti-caking agent silicone dioxide, olive oil, 3,7 % essential oils of spices Application as recommended by manufacturer: One tablet to be ingested with a glass of water (0,4 l) about 30 to 45 minutes before meal. The manufacturer intends to reduce the amount of food intake. It is not intended to reduce a certain food component e.g. fat or carbohydrates. Cost of a month supply: 49,80 € Composition and application of formoline L112 formoline L112 is filed under the pharmacy code number 271 87 24 According to manufactures information formoline L112 is a composition of natural indigestible fibre from crustaceans e.g. crawfish and shrimps. Further components are cellulose, vitamin c, tartaric acid, silicone dioxide and magnesium stearate. Application as recommended by manufacturer: Two tablets twice a day, taken with a fat-rich meal and 250 ml of water. The manufacturer intends to bind fat to the fibre and excrete it with the faeces. It is not intended to reduce the amount of food intake Cost of a month supply:114,00 € Slimtrax® vs. formoline L 112 3 Collection of data The volunteers were asked to check their body weight twice a month (every two weeks). Shorter intervals are not considered to be useful because body weight can fluctuate over the day as a result of beverage & food intake, and intestinal content. The volunteers were also asked to avoid “additional dietary interventions”. Privacy protection All data were collected anonymously. The volunteers got a guarantee that no third-party would have access to personal information (e.g. name, address, phone umber, fax number, email, medical history). They were assured that the data would not be released unless the information had been aggregated and de-identified making it anonymous. Third parties were only provided with aggregate statistics related to this trial. Results Table E1: Volunteer, male, Slimtrax® volunteer age SM 1 SM 2 SM 3 SM 4 SM 5 SM 6 SM 7 SM 8 27 35 44 47 48 30 39 33 height [cm] 188 179 185 180 187 190 177 187 bodyweight [kg] 105,4 96,6 108,2 98,3 112,7 105,7 95,1 112,8 2. 4. 6. 8. 103 96 106 96,9 111 104 93,5 111 101 94,6 104 95,5 110 102 91,9 110 99,4 93,2 102 94,1 108 99,2 90,3 108 97,7 91,9 101 93 106 97,1 88,8 107 week 10. 12. 14. 16. body weight [kg] 95,9 94,8 93,3 91,7 90,4 88,8 87,1 85,3 99,3 97,8 96,3 94,8 92,3 92,3 91,4 90,3 105 103 102 99,9 95,3 93,5 91,9 90,7 87,6 86,8 86,3 86,3 105 103 101 99,5 18. 20. 22. 24. 90,1 83,8 93,2 88,9 98,5 89,5 85,7 97,9 88,4 82,6 91,7 87,5 96,9 89 85,1 96,3 87 81,6 90,3 86,2 95,3 88,4 84,2 94,9 85,5 80,2 89 84,8 93,7 88,2 83,1 93,3 18. 20. 22. 24. 75,4 71,2 77,4 78,3 77,8 80,6 75 70,4 74 69,9 76,4 77,1 77,1 79,9 74,2 69,7 72,6 68,8 75,4 75,8 76,7 79,2 73,5 68,9 71,2 67,9 74,6 74,7 76,2 78,7 72,8 68,3 weight reduction [5] 18,9 17 17,7 13,7 16,9 16,6 12,6 17,3 16,3 Ø Table E2: volunteers, female, Slimtrax® volunteer SW SW SW SW SW SW SW SW 1 2 3 4 5 6 7 8 age 23 34 37 48 38 27 29 43 height [cm] 172 167 174 173 168 175 171 166 bodyweight [kg] 88 84 88,7 91,3 85,8 91,7 85,2 81,2 2. 4. 6. 8. 86,6 82,4 87,3 89,8 84,7 90,3 83,8 79,6 85,2 80,8 85,9 88,2 83,6 88,9 82,4 78 83,8 79,4 84,5 86,6 82,5 87,5 81,2 76,4 82,4 77,8 83,4 85,2 81,5 86,4 79,9 75,3 Table E3: volunteers, male, formoline L112 week 10. 12. 14. 16. bodyweight [kg] 81 79,6 78,2 76,8 76,3 75,1 73,8 72,4 81,9 80,7 79,7 78,6 83,9 82,4 80,9 79,7 80,6 79,8 79,2 78,6 85,2 84 82,7 81,6 78,8 77,7 76,4 75,7 74,2 73 72,2 71,3 weight reduction [%] 19,1 19,2 15,9 18,2 11,2 14,2 14,6 15,9 16 Ø Slimtrax® vs. formoline L 112 volunteer age KM 1 KM 2 KM 3 KM 4 KM 5 KM 6 KM 7 KM 8 28 35 32 37 46 45 41 33 hight [cm] 188 183 187 179 185 176 171 186 bodyweight [kg] 106,2 99,7 103,8 93,5 104,2 94,7 87,3 103,4 4 2. 4. 6. 8. 105,2 99,1 102,8 92,7 103,3 93,8 86,6 102,4 104,2 98,5 101,8 92 102,5 93 86 101,5 103,4 97,9 100,9 92,2 101,7 92,2 85,2 100,6 102,5 97,2 100 90,4 101 91,3 84,4 99,8 week 12. 14. bodyweight 101,6 100,9 99,9 96,4 95,8 95,1 99 98,2 97,3 89,7 89,1 88,4 100,1 99,2 98,5 90,5 89,6 88,7 83,6 82,9 82,1 98,8 98,1 97,1 10. 16. 18. 20. 22. 24. 99,1 94,5 96,4 87,8 97,9 87,8 81,2 96,1 98,3 93,7 95,5 87,2 97,5 87 80,5 95,2 97,9 93,1 94,7 86,5 96,9 86,3 79,7 94,3 97 92,5 93,8 85,9 96,3 85,4 78,9 93,4 96,4 91,9 92,9 85,3 95,7 84,6 78,2 92,4 weight reduction [%] 9,2 7,8 10,5 8,8 8,2 10,7 10,4 10,6 9,5 Ø Table E4: volunteer, female, formoline L112 volunteer KW KW KW KW KW KW KW KW 1 2 3 4 5 6 7 8 age 23 38 42 47 28 31 35 37 hight [cm] 176 171 169 163 172 173 173 175 bodyweight [kg] 90,8 88,5 87,6 77,4 86,7 89,7 90,7 93,8 2. 4. 6. 8. 90 88,1 87,1 76,8 85,9 88,9 90,2 93,2 89,2 87,7 86,5 76,2 85,1 88,2 89,7 92,6 88,4 87,3 85,9 75,7 84,3 87,5 89,3 92 87,7 87,1 85,3 75,1 83,6 86,6 88,8 91,3 week 10. 12. 14. 16. bodyweight [kg] 86,9 86,1 85,3 84,5 87 87 86,7 86,4 84,7 84 83,5 82,9 74,7 74,1 73,4 72,6 82,6 82 81,2 80,4 86 85,4 84,7 84,1 88,3 87,7 87,2 86,7 90,5 89,9 89,3 88,8 18. 20. 22. 24. 83,8 86 82,3 72,1 79,7 83,4 86,3 88,1 83,1 85,6 81,6 71,5 79 82,6 85,9 87,4 82,4 85,2 80,9 70,8 78,4 82 85,7 86,8 81,8 84,8 80,3 70,1 78 81,5 85,5 86,2 Comparison of the trial groups As expected, male volunteers lost more weight than females. So far the trial confirmed existing scientific results. The volunteers using Slimtrax® were much more successful than the volunteers using formoline L 112. The difference was statistically significant. The summarised results are displayed in graphic EG1. weight reduction [%] 9,9 4,2 8,3 9,4 10 9,1 5,7 8,1 8,1 Ø Slimtrax® vs. formoline L 112 5 EG1: Comparison of trial groups in % of weight reduction comparison of trial groups 18 16,3 16 16 14 12 9,5 10 8,1 8 6 4 2 0 SM SW KM SM SW KM KW KW SM = Slimtrax, male; SW = Slimtrax, female; KM = formoline, male; KW = formoline, female Summary In this trial the product Slimtrax® was much more successful than the product formoline L 112. During the trial period the volunteers using Slimtrax® achieved results approximately 100 % better than formoline L 112. The superior results of the Slimtrax® group can be explained by a different mode of action. While Slimtrax® reduces the total amount of food intake, formoline L 112 targets fat selectively. This mode of action is not effective with food and/or meals that are high in carbohydrates and protein. References 1. Teixeira PJ, Going SB, Houtkooper LB, Cussler EC, Metcalfe LL, Blew RM, Sardinha LB, Lohman TG. (2004) Pretreatment predictors of attrition and successful weight management in women. Int J Obes Relat Metab Disord. Sep;28(9):1124-33. 2. Linde JA, Jeffery RW, Levy RL, Pronk NP, Boyle RG. (2005) Weight loss goals and treatment outcomes among overweight men and women enrolled in a weight loss trial. Int J Obes (Lond). Aug;29(8):1002-5. Slimtrax® vs. formoline L 112 6 3 . Teixeira PJ, António L Palmeira, Teresa L Branco, Sandra S Martins, Cláudia S Minderico, José T Barata, Analiza M Silva and Luís B Sardinha (2004) Who will lose weight? A reexamination of predictors of weight loss in women International Journal of Behavioral Nutrition and Physical Activity, 1: 12 (online – publication) 4. Dionne I, Despres JP, Bouchard C, Tremblay A. (1999) Gender difference in the effect of body composition on energy metabolism. Int J Obes Relat Metab Disord. Mar;23(3):312-9. 5. Wirth A, Steinmetz B. (1998) Gender differences in changes in subcutaneous and intra-abdominal fat during weight reduction: an ultrasound study. Obes Res. Nov;6(6):393-9. 6. Wing RR, Jeffery RW. (1995) Effect of modest weight loss on changes in cardiovascular risk factors: are there differences between men and women or between weight loss and maintenance? Int J Obes Relat Metab Disord. Jan;19(1):67-73.