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临床试验/NCT05191030
NCT05191030已完成不适用

Food Insecurity, Poor Diet, and Metabolic Syndrome: Cortisol's Amplifying Role

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2022年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
453
试验地点
1
主要终点
Hyperpalatable Food Intake Measured in Kilocalories

研究概览

简要总结

This study used a within-subjects design in a sample of individuals with a range of food insecurity recruited from the Los Angeles community (N = 400; 44.5% men). These participants then, in counterbalanced order, were exposed to a gold-standard laboratory stressor and a control condition, one month apart. Moderation analyses will test whether cortisol reactivity to the stressor acts as a modulator of the relationship between high levels of food insecurity and increased hyperpalatable food intake.

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
Single (Participant)

入排标准

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

入选标准

  • •English-speaking

排除标准

  • •Recent (<1 year) diagnosis of major psychiatric disorders including any mood disorder, schizophrenia, or PTSD
  • •Recent (<1 year) diagnosis of eating disorder
  • •Recent (<1 year) diagnosis of metabolic or endocrine disorder or steroid or hormonal contraceptive use
  • •Pregnancy
  • •Allergy to any of the foods in the food buffet
  • •Participation in strict dieting or caloric restriction

研究组 & 干预措施

Experimental (High Stress) First, Then Control

Experimental

Participants first completed the high-stress condition in which they were exposed to a gold-standard laboratory stressor, the Trier Social Stress Test (Kirschbaum et al., 1993). Participants were given five minutes to prepare for a five-minute speech task followed by a five-minute mental arithmetic task in front of two panelists wearing white lab coats (i.e., a male and female research assistant). The speech task put the participant in a mock interview, with the panelists listening to the speech in an unresponsive, neutral manner and asking standardized probing questions. During the mental arithmetic task, participants were instructed to subtract odd numbers (i.e., 7 and 13) from a large number (i.e., 2935) as quickly as possible. If the participant made a mistake, the panelist interrupted them and instructed them to start the task again from the beginning. The panelists reminded the participant to "go faster" if they started to slow down with the task.

干预措施: High-Stress Intervention (Behavioral)

Control First, Then Experimental (High Stress)

No Intervention

Participants first underwent the control condition during which they were presented with low-stress equivalents to the speech and mental arithmetic tasks from the experimental (high-stress) condition. For the speech task, participants were instructed to talk out loud to themselves for five minutes about a movie or book of their choice. Their speech was recorded using a small audio recorder device the research assistant prepared. For the mental arithmetic task, participants were instructed to count by increments of 15 starting from zero to the largest number they could reach. Participants were left in the room alone for the task for five minutes, after which the participant self-reported to the research assistant the number they reached.

结局指标

主要结局

Hyperpalatable Food Intake Measured in Kilocalories

时间窗: Hyperpalatable food intake was measured twice: 5 minutes following the experimental (high stress) or control condition during the first visit, and again 5 minutes following the alternate condition during the second visit.

The primary outcome was hyperpalatable food intake, initially measured in grams and converted into kilocalories. The food consisted of the following items: donuts, M\&Ms, potato chips, crackers, and Sprite. These foods were chosen because processed foods, added sugars, refined grains, starchy vegetables, and sugar sweetened beverages are foods to avoid according to the 2019 American Diabetes Association Nutrition Consensus Report and are high in carbohydrates and glycemic index.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Janet Tomiyama

Associate Professor

University of California, Los Angeles

研究点 (1)

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