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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06411483
• Other study ID #: 30015228
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2024
• Source: Concordia University, Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Obesity, Metabolically
• Obesity
• Obesity, Metabolically Benign

Intervention

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

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

Locations

Country	Name	City	State
Canada	School of Health, Concordia University	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Concordia University, Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors involved with appetite regulation	Blood hormones and proteins involved with appetite regulation. Appetite will be assessed via the Adult Eating Behaviour Questionnaire to see changes from baseline. This is a 35-item questionnaire that assesses 8 traits of appetite/hunger on a 1-5 Likert scale with a score of 1 indicating "strongly disagree" and a score of 5 indicating "strongly agree" to the statement.	after 2 weeks of wearing the band
Primary	Dietary assessment	Changes in dietary intake will be measured through 3 day food records combined with photos.	after 2 weeks of wearing the band
Primary	Physical activity	Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) to see changes from baseline. The questionnaire measures various dimensions of physical activity over a 7 day retrospective period. The questions are open ended, asking participants to fill out a number for the time period being asked. For example, "___days per week".	after 2 weeks of wearing the band