CLINICAL STUDIES 2012
Clinical Study – Women
The Adipotronics™ clinical study on targeted fat loss was managed by a team of scientific experts made up of: Alain Steve Comtois – Investigator, Jean P. Boucher – Project Manager, James A. Hodgdon – Statistician, André Cyr, MD – Scientific Collaborator, and Zied Haj Hamida – Coordinator. The clinical study was also supervised by the Independent Ethical Review Board of the centre médical et centre de santé de la femme Ville-Marie. The clinical study was performed from May 12 to July 22, 2012.
PARTICIPANTS & SELECTION CRITERIA
- 35 women
- Age: between 25 and 45 years old
- Targeted areas: thighs
- Good health (PAR-Q)
- Randomnised selection
- Body Mass Index (BMI): between 22 and 35
- 30 sessions in 10 weeks
- Circuit of 6 exercises
- 5 minutes warm-up
- 30 minutes exercises
- 10 minutes cool-down
Type of Exercises
- Low intensity interval training
- Training phase: 50 % to 65 % of maximal heart rate
- Active rest phase: 35 % to 45 % of maximal heart rate
Examples of Exercises
- Testing divided into 6 stations, in addition to the welcome table
- Greeting of the participants, explanation of the procedures and distribution of the evaluation sheets
- Station 1 – Body composition: weight, height, body mass index (BMI), skinfolds, circumferences and percentage of body fat through BIA
- Station 2 – Body composition through DEXA
- Station 3 – Aerobic capacity: submaximal test to identify the exercise heart rate
- Station 4 – Blood sample: blood lipids and triglycerides
- Station 5 – Thickness of the subcutaneous fat layer: measured through ultrasound
- Station 6 – Pictures (anterior, posterior and lateral views).
- 3 test-periods over 3 weekends
- Half of the participants were tested on Saturday and the other half on Sunday
- Participants were scheduled at one of the 6 test times :
- Group 1: 8:00 am
- Group 2: 9:30 am
- Group 3: 12:00 pm
- Group 4: 1:30 pm
- Group 5: 4:00 pm
- Group 6: 5:30 pm
- Test 1: Saturday, May 12 and Sunday, May 13
- Test 2: Saturday, June 16 and Sunday, June 17
- Test 3: Saturday, July 21 and Sunday, July 22
- Beginning : Monday, May 14
- End : Thursday, July 19
- Training days : Monday, Wednesday and Thursday
DELAYS AND ABSENCES
- The presence to the tests was mandatory.
- 2 absences to the training sessions automatically resulted in a withdrawal from the clinical study.
- 2 delays equal to an absence.
- 4 delays to the training sessions then automatically resulted in a withdrawal from the clinical study.
COMPENSATION AND COMMITMENT
- Participants received $1,000. The compensation covered parking and transportation fees for the 33 required presences (30 training sessions and 3 tests).
- At the onset of the project, participants signed an informed consent document approved by the Independent Ethical Review Board of the centre médical et centre de la santé de la femme Ville-Marie.
- Participation implied a moral commitment to complete the whole project.
Clinical Study – Men
A clinical study managed by the same team of scientific experts was conducted with 12 men. The targeted area was the abdomen for this group which trained 3 times a week, for a 10-week period. No compensation was offered to these participants.
Comparative Clinical Study
A clinical study managed by the same team of scientific experts was conducted with 8 women and 8 men. Half of the participants consumed a high-fat meal and the other half used the electrical stimulator for 4 hour, without exercising. The targeted areas were the thighs (women) and the abdomen (men). This study was performed in order to show that there is no risk associated with the circulation of lipids (fat cells) in the blood while using the stimulator at rest.
CLINICAL STUDY 2007
Clinical Study – Women
A clinical study was performed in 2007 on 24 healthy but overweight women, ranging from 18 to 42 years old. Some of the participants were wearing the stimulator with Adipotronics™ technology during the training program while the other participants were exercising without it.
*The results of the clinical studies will be available soon.