Selection and allocation of the volunteers

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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.
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