Effect of Acute ObeEnd Exposure on Factors Regulating Appetite

NCT06487234 | Recruiting

• 1 other identifier: 30015229
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Acupuncture; Wearable wellness device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Blood Pressure

  Baseline to after stimulation, on average 1 hour

• Heart rate

  Baseline to after stimulation, on average 1 hour

Study Arms (2)

Functional band

ACTIVE COMPARATOR

Device: Functional band

Nonfunctional band

PLACEBO COMPARATOR

Device: Placebo band

Interventions

Functional band DEVICE

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

Functional band

Placebo band DEVICE

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

Nonfunctional band

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People with obesity (BMI\>30kg/m2)
• Generally healthy
• Premenopausal females

You may not qualify if:

• 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)

Sponsors & Collaborators

• Concordia University, Montreal: lead

Study Sites (1)

Concordia University

Montreal, Quebec, H4B1R6, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvia Santosa, PhD, RD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvia Santosa, PhD

CONTACT

514-848-2424; s.santosa@concordia.ca

Anjalee I Wanasinghee

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 5, 2024
• Study Start: July 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
• Access Criteria: On request with ethics approval.

Locations

CA (1)