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临床试验/NCT06569043
NCT06569043已完成不适用

Appetite Responses to Breakfast Bar Product: a Randomized Controlled Trial

General Mills2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月20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
120
试验地点
2
主要终点
Visual Analogue Scale for Hunger 0-240 minutes

研究概览

简要总结

The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults 18-70 years
  • Habitual snack bar consumers (at least several times per month)
  • Body mass index 18.5-29.9 kg/m2 (based on self-reported weight and height)
  • Understand and willing to follow the study procedures
  • Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
  • Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before the test day
  • Willing to provide informed consent to participate in the study

排除标准

  • Pregnant or lactating women, or women who are planning to become pregnant during the study
  • Known food allergies, sensitivities, or intolerance to any food or food ingredients
  • Participating in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
  • Taking medications that affect appetite, metabolism or blood pressure
  • Presence of acute diseases or infection
  • Presence or history of chronic diseases
  • Diagnosed with an eating disorder
  • Restraint eaters as determined by a score >4 from the Dutch Eating Behavior Questionnaire
  • Lost or gained 5 or more pounds in the past 3-months
  • On a weight loss diet or undergoing intermittent fasting
  • COVID-19 infection within the past 3 months
  • Subjects who do not eat bar products

结局指标

主要结局

Visual Analogue Scale for Hunger 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how hungry are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more hunger. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.

Visual Analogue Scale for Fullness 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how full are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more fullness. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.

Visual Analogue Scale for Satiation 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how satiated are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satiation. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.

Visual Analogue Scale for Desire to Eat 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how strong is your desire to eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more desire to eat. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.

Visual Analogue Scale for Prospective Consumption 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how much do you think you can eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more prospective consumption. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome.

Visual Analogue Scale for Satisfaction 0-240 minutes

时间窗: 240 minutes

Visual Analogue Scale for "how satisfied are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satisfaction. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome.

次要结局

未报告次要终点

研究者

发起方
General Mills
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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