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

NCT ID: NCT06411483

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Healthy Obesity, Metabolically; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active Band

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

Group Type: ACTIVE_COMPARATOR

ObeEnd Band

Intervention Type: DEVICE

The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Interventions

ObeEnd Band

The ObeEnd band provides electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Intervention Type: DEVICE

Placebo

The nonfunctional ObeEnd band does not provide electrostimulation to the PC6 acupuncture point on the wrist for 30 minutes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Sylvia Santosa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvia Santosa, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Locations

School of Health, Concordia University

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

30015228

Identifier Type: -

Identifier Source: org_study_id