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临床试验/NCT03112161
NCT03112161已完成不适用

The Effects of Energy Imbalance on Food Intake Behaviors

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2005年6月14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
76
试验地点
2
主要终点
Change in neuronal response to food vs. nonfood objects in fasted vs. fed states

研究概览

简要总结

This study will determine whether changes in energy balance alter regional neuronal activation of brain regions associated with food intake in individuals screened to be either resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic" value elicit changes in regional neuronal activity in the fasted and fed state in "obese-resistant" and "obese-prone" men and women in varying states of energy balance.

研究设计

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

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In the obese-prone group:
  • BMI between 20-30
  • Report at least one obese first-degree relative
  • Self-describe as "struggling" with weight
  • Weight-stable for at least 3 months prior to study participation
  • In the obese-resistant group:
  • BMI between 17-25
  • Report no obese first-degree relatives
  • Self-describe as "naturally thin" and have never been overweight
  • Overall weight stability

排除标准

  • Significant medical or psychiatric disease
  • History of eating disorder
  • Left handed
  • Unable to complete an MRI scan (e.g., metal in body, claustrophobic)

结局指标

主要结局

Change in neuronal response to food vs. nonfood objects in fasted vs. fed states

时间窗: Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding)

Change in neuronal response to food vs. nonfood objects in the overfed and underfed feeding periods as compared to the eucaloric period between fasted and fed states in obese-prone as compared to obese-resistant individuals.

次要结局

  • Change in food cravings(At baseline and both before and after a meal on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding).)
  • Change in neuronal response to hedonic vs. basic food images(Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding))
  • Change in body weight(Baseline and every 6 months for up to 5 years after study participation.)
  • Change in leptin levels(At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.)
  • Change in ghrelin levels(At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.)
  • Change in appetite ratings(At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.)
  • Change in PYY levels(At baseline, in the fasted state on Day 5 of each of the three 5-day study periods (Eucaloric, Overfeeding, Underfeeding) and at 30, 90, 120, 150 and 180 minutes after a meal on Day 5 of each of the three 5-day study periods.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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