Recruiting

Observational Study

Sponsor:

Concordia University, Montreal

Code:

NCT06487234

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Functional band

Placebo band

Study Details

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

Study ID

NCT06487234

Start date

Jul 5, 2024

Status verified date

May, 2024

Completion date

Apr 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Functional band

placebo comparator: Nonfunctional band

Interventions

Functional band

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

Placebo band

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

Primary outcome measure

  • Appetite assessment [ Time Frame: Baseline to 4 hours ]
  • Blood Hormones [ Time Frame: Baseline to 4 hours ]

Central Contacts and Locations

Central contacts

Locations

Concordia University

Recruiting

Montreal, Quebec, Canada, H4B1R6

Contacts

More Information

Sponsor

Concordia University, Montreal

Last update posted

Jul 5, 2024

Last verified

May, 2024

Keywords

  • Acupuncture
  • Wearable wellness device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Concordia University, Montreal on 2024-07-05.