Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Device: Placebo band; Device: Functional band

• Registration Number: NCT06487234
• Lead Sponsor: Concordia University, Montreal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study Start: 2024-07-05
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-12-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nonfunctional band	Placebo band	-
Functional band	Functional band	-

Primary Outcome Measures

Name	Time	Method
Blood Hormones	Baseline to 4 hours	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.
Appetite assessment	Baseline to 4 hours	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.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline to after stimulation, on average 1 hour	Blood pressure will be measured (mmHg)
Heart rate	Baseline to after stimulation, on average 1 hour	Heart rate will be measured (beats per minute)

Trial Locations

Locations (1)

Concordia University; 🇨🇦 Montreal, Quebec, Canada