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n Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.
To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, acute electrostimulation of PC6 an acupuncture spot on the wrist for a 1 hour period will result in changes in enterogastric hormones in a direction that decreases appetite. This study will provide the first evidence of the acute effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional band | Active Comparator |
| |
| Nonfunctional band | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional band | Device | Participants will wear the functional band for 1-hour electroacupuncture stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appetite assessment | Perceived appetite as reported based on the Visual Analog Scale after a standardized mixed meal. Appetite will be assessed every 30 minutes over a 2 hour period post meal consumption, at 30, 60, 90 and 120 minutes. The Visual Analog Scale is a measure of appetite based on a 10 cm line. Participants are asked a question on how they feel about a specific aspect of appetite (e.g. hunger). Participants then place a mark on the line. A mark closer to the left indicates fullness and satiation and a mark closer to the right indicates hunger. | Baseline to 4 hours |
| Blood Hormones | Fasting blood hormone levels will be measured prior to stimulation, and every 30 minutes over a 2 hour period post meal consumption, (at 30, 60, 90 and 120 minutes). Blood hormones involved in appetite and motility such as ghrelin, glucagon-like peptide 1, motilin, and pepsinogen-1 will be measured via ELISA. | Baseline to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Blood pressure will be measured (mmHg) | Baseline to after stimulation, on average 1 hour |
| Heart rate | Heart rate will be measured (beats per minute) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Santosa, PhD | Contact | 514-848-2424 | 5841 | s.santosa@concordia.ca |
| Anjalee I Wanasinghee | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Sylvia Santosa, PhD, RD | Concordia University, Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia University | Recruiting | Montreal | Quebec | H4B1R6 | Canada |
On request and approval by ethics
The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
On request with ethics approval.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo band | Device | Participants will wear the nonfunctioning band for 1-hour with no electroacupuncture stimulation |
|
| Baseline to after stimulation, on average 1 hour |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |