Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

Determining the Physiological Mechanism Behind Acute ObeEnd Device Exposure on Factors Regulating Appetite

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: Functional band; Device: Placebo band

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvia Santosa, PhD; Phone Number: 5841 514-848-2424; Email: s.santosa@concordia.ca
• Study Contact Backup: Name: Anjalee I Wanasinghee

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4B1R6
      • Recruiting
      • Concordia University
      • Contact: Sylvia Santosa, PhD; Phone Number: 5841 514-848-2424; Email: s.santosa@concordia.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Functional band	Device: Functional band; Participants will wear the functional band for 1-hour electroacupuncture stimulation
Placebo Comparator: Nonfunctional band	Device: Placebo band; Participants will wear the nonfunctioning band for 1-hour with no electroacupuncture stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Baseline to after stimulation, on average 1 hour

Collaborators and Investigators

• Sponsor: Concordia University, Montreal
• Investigators: Principal Investigator: Sylvia Santosa, PhD, RD, Concordia University, Montreal

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; Wearable wellness device
• Other Study ID Numbers: 30015229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request and approval by ethics
• IPD Sharing Time Frame: The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
• IPD Sharing Access Criteria: On request with ethics approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No