Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite

Concordia University, Montreal

Status: Completed

Conditions: Healthy Obesity, Metabolically; Obesity

Treatments: Device: ObeEnd Band; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06411483

30015228

Details and patient eligibility

About

In 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, electrostimulation of PC6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. The investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI >30 kg/m2
• no history of chronic illness or disease
• premenopausal

Exclusion criteria

• pregnant, breastfeeding
• medications that may affect outcomes
• chronic disease or conditions that may affect outcomes
• smoking or use of nicotine containing products

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

27 participants in 2 patient groups, including a placebo group

Active Band

Active Comparator group

Description:

Participants in this group will receive an active band which provides electrostimulation at PC6

Treatment:

Device: ObeEnd Band

Placebo

Placebo Comparator group

Description:

Participants in this group will receive an inactive band which does not provide any electrostimulation when turned on.

Treatment:

Other: Placebo