Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

Concordia University, Montreal

Status: Enrolling

Conditions: Obesity

Treatments: Device: Functional band; Device: Placebo band

Study type: Interventional

Funder types: Other

Identifiers

NCT06487234

30015229

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People with obesity (BMI>30kg/m2)
• Generally healthy
• Premenopausal females

Exclusion criteria

• Past (<1 year) or present use of nicotine products
• History of chronic disease or metabolic conditions
• Females who are pregnant, less than 6 months postpartum, or breastfeeding
• Diagnosed hepatic disease, renal impairment, uncontrolled hypothyroidism
• Use of any medications that may affect study outcomes (e.g. hormone replacement therapy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Functional band

Active Comparator group

Treatment:

Device: Functional band

Nonfunctional band

Placebo Comparator group

Treatment:

Device: Placebo band