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临床试验/NCT04219189
NCT04219189已完成不适用

The Acute Effect of Vaping on Food Intake

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Energy Intake

研究概览

简要总结

This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode

详细描述

Weight control is a common motive for cigarette smoking and nicotine has been shown to suppress appetite and increase resting metabolic rate, and also serves as a behavioral alternative to eating or a distraction from hunger or food craving. Data on the acute effect of e-cigarette use ('vaping') on ad libitum food intake are non-existent. Given that many e-cigarette users report vaping for weight control and that certain e-cigarettes are being actively marketed for weight management and/or suppression of food cravings, addressing this research gap is of the utmost importance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • 18 - 65 years of age (ID card verified)
  • Reports either everyday e-cigarette use with liquid containing at least 0.3% (~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (~30 mg/ml) nicotine for the past 30 days.

排除标准

  • being unwilling to consume the foods provided due to: a) dietary limitations or preferences or b) allergies to the foods provided.
  • being unwilling to take 20 puffs from a JUUL device containing a 5% nicotine pod
  • self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
  • observed high blood pressure at screening (systolic >140; diastolic >90)
  • other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor
  • self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use
  • past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs
  • self-report of >25 days out of the past 30 for alcohol use or >20 days out of the past 30 for cannabis use.
  • women who are breast-feeding or test positive for pregnancy (by urinalysis at screening)
  • women using progestin-IUDS for birth control
  • women using birth control injections (e.g., Depo-Provera)
  • women who received a hysterectomy and still have ovaries present
  • self-report intending to quit tobacco/nicotine products in the next 30 days

结局指标

主要结局

Energy Intake

时间窗: intake was assessed over a 30 minute meal

Energy intake in kilocalories (kcal) during the ad libitum buffet meal will be measured via directly weighed food provision and waste (food/energy intake is calculated by difference).

次要结局

  • Dietary Added Sugar Intake(intake was assessed over a 30 minute meal)
  • Dietary Carbohydrate Intake(intake was assessed over a 30 minute meal)
  • Dietary Sugar Intake(intake was assessed over a 30 minute meal)
  • Dietary Fat Intake(intake was assessed over a 30 minute meal)
  • Dietary Protein Intake(intake was assessed over a 30 minute meal)
  • Dietary Cholesterol Intake(intake was assessed over a 30 minute meal)
  • Dietary Fiber Intake(intake was assessed over a 30 minute meal)
  • Dietary Potassium Intake(intake was assessed over a 30 minute meal)
  • Dietary Saturated Fat Intake(intake was assessed over a 30 minute meal)
  • Dietary Vitamin D Intake(intake was assessed over a 30 minute meal)
  • Difference in Food Cravings(The FCQ-State was administered about 30 minutes after either the vaping or non-vaping (control) condition and about ~20 minutes before the ad lib buffet meal.)
  • Dietary Calcium Intake(intake was assessed over a 30 minute meal)
  • Dietary Iron Intake(intake was assessed over a 30 minute meal)
  • Dietary Sodium Intake(intake was assessed over a 30 minute meal)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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