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临床试验/NCT06411483
NCT06411483已完成不适用

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

Concordia University, Montreal2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Factors involved with appetite regulation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will be randomized to receive active or placebo (inactive) bands.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI >30 kg/m2
  • no history of chronic illness or disease
  • premenopausal

排除标准

  • pregnant, breastfeeding
  • medications that may affect outcomes
  • chronic disease or conditions that may affect outcomes
  • smoking or use of nicotine containing products

结局指标

主要结局

Factors involved with appetite regulation

时间窗: after 2 weeks of wearing the band

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.

Dietary assessment

时间窗: after 2 weeks of wearing the band

Changes in dietary intake will be measured through 3 day food records combined with photos.

Physical activity

时间窗: after 2 weeks of wearing the band

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".

次要结局

未报告次要终点

研究者

发起方
Concordia University, Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvia Santosa

Professor

Concordia University, Montreal

研究点 (2)

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