Overweight
Conditions
Brief summary
The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.
Detailed description
Obesity and Overweight had become the number 1 health concern of the modern world. Over 1 Billion people worldwide are overweight or obese. Those who suffer from overweight or obesity are exposed to other severe illnesses such as: diabetes, cardiovascular disease and cancer. Only few drugs and surgeries are currently available as approved treatments for those who wish to reduce weight. The purpose of this study is to determine whether the SD unique medical device, is effective in treatment of overweight and obesity.
Interventions
DEVICESD
The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance. The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss. The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements.
DEVICEControl
The participants in the Control arm of the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the placebo. During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the placebo is done by the control study participants during the day every day throughout the study period. The placebo can be easily used by the participants themselves in their regular environment and does not require professional assistance.
Sponsors
Beck Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI 30-41.99 * AGE 18-65 years
Exclusion criteria
* Pregnant Women, * Type I and II diabetes, * People with disfunctioning of thyroid gland * Hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Body Weight | once in every two weeks up to 13 weeks for each participant | Each participant's body weight will be measured at his/her beginning of the trial. This measure will become the participant's body weight base-line. Once in every 2 weeks the body weight will be taken again and will be compared to base-line and to previous body weight measures of the participant taken during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Waist Circumference | once in every two weeks up to 13 weeks for each participant | Each participant's Waist circumference will be measured at his/her beginning of the trial. This measure will become the participant's Waist circumference base-line. Once in every 2 weeks the Waist circumference will be taken again and will be compared to base-line and to previous Waist circumference measures of the participant taken during the study. |
Countries
Israel
Contacts
Primary ContactBeck Medical
Outcome results
None listed