Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

NCT ID: NCT06487234

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-05
• Study Completion Date: 2025-04-01

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Functional band

Group Type: ACTIVE_COMPARATOR

Functional band

Intervention Type: DEVICE

Participants will wear the functional band for 1-hour electroacupuncture stimulation

Nonfunctional band

Group Type: PLACEBO_COMPARATOR

Placebo band

Intervention Type: DEVICE

Participants will wear the nonfunctioning band for 1-hour with no electroacupuncture stimulation

Interventions

Functional band

Participants will wear the functional band for 1-hour electroacupuncture stimulation

Intervention Type: DEVICE

Placebo band

Participants will wear the nonfunctioning band for 1-hour with no electroacupuncture stimulation

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Santosa, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Locations

Concordia University

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sylvia Santosa, PhD

Role: CONTACT

s.santosa@concordia.ca

514-848-2424 ext. 5841

Anjalee I Wanasinghee

Role: CONTACT

Facility Contacts

Sylvia Santosa, PhD

Role: primary

s.santosa@concordia.ca

514-848-2424 ext. 5841

Other Identifiers

30015229

Identifier Type: -

Identifier Source: org_study_id